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General Information / 1251 Weighing on an Analytical Balance 1597

USP 38

Table 1. Standard Saturated Salt Solutions (Continued)

Saturated Salt
Solutions at 25
Magnesium nitrate (Mg(NO3)2)

ERH
(%)

AW

52.9

0.529

Magnesium chloride (MgCl2)

32.8

0.328

Lithium chloride (LiCl2)

11.2

0.112

1251 WEIGHING ON AN ANALYTICAL BALANCE

INTRODUCTION

QUALIFICATION
Users should consult Analytical Instrument Qualification 1058, standard operating procedures, and recommendations from
manufacturers when they devise qualification plans.

Installation
The balance's performance depends on the conditions of the facility where it is installed. Analysts should consult information
provided by the manufacturer before they install a balance.
Support surface: The balance should be installed on a solid, level, nonmagnetic surface that minimizes the transmission
of vibration (e.g., a floor-mounted, granite weigh bench). If a metallic support surface is used, the surface should be grounded
in order to prevent the buildup of static electricity.
Location: If possible, the balance should be located in a room that is temperature and humidity controlled. The location
should have a clean, consistent electrical power supply. The location should be free of drafts and should not be near ovens,
furnaces, air conditioner ducts, or cooling fans from equipment or computers. The balance should be positioned away from
outside windows so that direct sunlight does not strike the balance. The balance should not be installed near sources of electromagnetic radiation such as radio-frequency generators, electric motors, or hand-held communication devices (including
cordless telephones, cellular telephones, and walkie-talkies). The balance should not be located near magnetic fields induced
by laboratory instrumentation or other equipment.
The performance of the balance should be assessed following installation and before use in order to demonstrate adequate
performance. In some situations, it may not be possible to position the balance in an optimum environment. Examples of potential facility issues include the following:
1. Air currents sometimes are present in the laboratory.
2. Temperatures in the laboratory vary excessively (check the manufacturer's literature about temperature sensitivity).
3. Humidity is either very low or very high. Either condition may increase the rate at which the sample weight varies because
of pickup or loss of water. Low humidity increases the buildup of static electricity.
4. Adjacent operations are causing vibration.
5. Corrosive materials are used nearby or are routinely weighed.
6. The balance is located within a fume hood because it is used to weigh corrosive or hazardous materials.
7. The balance is adjacent to equipment that produces a magnetic field (e.g., a magnetic stirrer).
8. Direct sunlight strikes the balance.

1 National Physical Laboratory. Good practice guide No. 70, weighing in the pharmaceutical industry. 2004. http://resource.npl.co.uk/docs/science_technology/
mass_force_pressure/clubs_groups/instmc_weighing_panel/pharmaweigh.pdf. Accessed 21 March 2012. [NOTENomenclature in this chapter tends to follow this
document, except where it conflicts with USP terms.]
2 American Society for Testing and Materials. E898 Standard test method of testing top-loading, direct-reading laboratory scales and balances. 2005. http://
www.astm.org/Standards/E898.htm. Accessed 21 March 2012.

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General Chapters

Weighing is a frequent step in analytical procedures, and the balance is an essential piece of laboratory equipment. The general information described here applies directly to electronic balances used in analytical procedures. Although many portions
of the chapter are applicable to all balances, some are applicable only to analytical balances. This chapter should not be considered all-inclusive, and other sources of information (e.g., the US National Institute for Science and Technology and balance
manufacturers) may be useful and applicable when analysts perform a weighing operation or implement a weighing procedure.1,2 The information given in this chapter is applicable not only to balances used for materials that must be accurately
weighed (see Balances 41) but also to balances used in all analytical procedures.

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In situations when the balance is located near equipment or systems that induce vibration, drafts, electromagnetic radiation,
magnetic fields, or changes in temperature or humidity, the assessment should be conducted with those systems operating in
order to duplicate a worst-case scenario.

General Chapters

Operational Qualification
An operational qualification should be performed either by the user or by a qualified third-party vendor after the equipment
has been installed.
As a minimum, the power should be turned on and the balance should be allowed to equilibrate according to the manufacturer's instructions (124 h, depending on the type of balance) before use. Depending on the balance, analysts should include
the following procedures in the operational qualification:
1. Mechanical mobility of all moveable parts
2. Control of stable indication
3. Manually triggered or automatic adjustment by means of built-in weights
4. Operation of ancillary equipment
5. Tare function
6. Initial calibration
Several types of electronic analytical balances use built-in weights for manually triggered or automatic adjustment. This adjustment usually is applied to reduce the drift of the balance over time and to compensate for drifts caused by variations in the
ambient temperature.
Calibration normally is performed as part of the operational qualification, but it also can be performed periodically thereafter. Calibration should be performed at the location where the balance is used in normal operation.

Performance Qualification
Table 1 provides a list of the most important balance properties that should be assessed during performance qualification.
Depending on the risk of the application and the required weighing process tolerance, some of these tests may be omitted.
Tests also can be omitted if there is evidence that the property in question has only minimal effect on the weighing performance. Any procedures used should be consistent with in-house standard operating procedures, applicable for the specific balance, and adequately justified. Performance qualification should be performed periodically as described in standard operating
procedures, and the frequency of each of the individual tests can vary depending on the criticality of the property.
Table 1. Suggested Performance Tests and Acceptance Criteria
Property

Definition

Examples

Acceptance Criteria

Sensitivity

Change in weighing value divided by the

change in load, usually measured between zero and the capacity of the balance.

The test load at or sufficiently close to the

capacity of the balance.

NMT 0.05% deviation where 41 is applicable. For other uses, respective tolerance requirement divided by 2.

Linearity

Ability of a balance to follow the linear relationship between a load and the indicated weighing value. Nonlinearity usually is expressed as the largest magnitude of any linearity deviation within the
test interval.

From 3 to 6 points over the range of the

balance.

NMT 0.05% deviation where 41 is applicable. For other uses, respective tolerance requirement divided by 2.

Eccentricity

Deviation in the measurement value

caused by eccentric loadingin other
words, the asymmetrical placement of
the center of gravity of the load relative
to the load receiver. Eccentricity usually
is expressed as the largest magnitude of
any of the deviations between an offcenter reading and the center reading
for a given test load.

Performed in the center of gravity and the

four quadrants (for rectangular platter
shapes) or at analogous locations for
other platter shapes. Test load usually
should be 30% of the capacity of the
balance or higher (refer to the manufac- NMT 0.05% deviation where 41 is appliturer's manual for any possible upper
cable. For other uses, respective tolerlimit).
ance requirement divided by 2.

Repeatability

Ability of a weighing instrument to display identical measurement values for repeated weighings of the same objects
under the same conditions, e.g., the
same measurement procedure, same operator, same measuring system, same
operating conditions, and same location
Requirement from 41 where applicable.
over a short period of time. Repeatability 10 replicate weighings (using a test
usually is expressed as the standard devi- weight that is a few percent of the nomi- For other uses, user specified requireation of multiple weighings.
nal capacity of the balance).
ments will apply.

The weights that are used to perform the tests should be stored and handled in a manner that minimizes contamination.
Before executing the tests, the analyst should place the weights in the vicinity of the balance for an appropriate time to reach

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General Information / 1251 Weighing on an Analytical Balance 1599

Balance Checks
A balance check using an external weight helps ensure that the balance meets weighing tolerance requirements. The balance check is performed at appropriate intervals based on applicable standard operating procedures. The frequency of the balance check depends on the risk of the application and the required weighing tolerance. Checks with external weights can be
replaced partially using automatic or manually triggered adjustment by means of built-in weights. When analysts perform the
balance check with an external weight, the same acceptance criteria may apply as described in the sensitivity test above.

Minimum Weight
The minimum net sample weight, mmin, of a balance can be expressed by the equation:
mmin = k s/required weighing tolerance
where k is the coverage factor (usually 2 or larger) and s is the standard deviation (in a mass unit, e.g., in mg) of not fewer
than 10 replicate measurements of a test weight. The minimum weight describes the lower limit of the balance below which
the required weighing tolerance is not adhered to. The equation above takes into account that the performance of laboratory
balances at the lower end of the measurement range is limited by the finite repeatability.
For materials that must be accurately weighed, 41 stipulates that repeatability is satisfactory if two times the standard deviation of the weighed value, divided by the nominal value of the weight used, does not exceed 0.10%. For this criterion the
equation above simplifies to:
mmin = 2000 s
If not subject to the requirements of 41, the minimum weight value may vary depending on the required weighing tolerance and the specific use of the balance.

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General Chapters

sufficient thermal equilibrium. If possible, all tests should be carried out with a single test weight in order to minimize handling
errors, but multiple test weights are permitted.
The tests should be recorded in such a manner that the data can be used to easily track balance performance and to assist in
laboratory investigations as needed. Meaningful acceptance criteria can be set depending on the required weighing tolerance,
i.e., the maximum allowed deviation permitted by specifications, regulations, etc., of a quantity to be weighed from its target
value. Procedures should be in place to address test results that are outside acceptable ranges and to provide assurance that
balance cleanliness and environment have not affected the result. Also, a procedure should be in place for removing a balance
from operation when observed results fall outside acceptable ranges.
Sensitivity, linearity, and eccentricity all account for systematic deviations; i.e., they limit the accuracy of the balance (based
on the definition of accuracy in Validation of Compendial Procedures 1225 and ICH Q2). In the International Vocabulary of
Metrology (VIM) and documents of the International Organization for Standardization, this concept is referred to as trueness.
Because deviations are largely independent from each other, it is not likely that all deviations occur simultaneously and have
the same algebraic sign. Therefore the arithmetic addition of all individual deviations to assess the balance accuracy would
constitute a rather conservative approach. A quadratic addition of the individual deviations is a more realistic approach. By
allocating 50% of the weighing tolerance budget to the acceptance criteria of the individual properties, e.g., sensitivity, linearity, and eccentricity, analysts ensure adherence to the required weighing tolerance. Therefore, the acceptance criteria for the
individual properties that account for the systematic deviations are set to weighing tolerance divided by 2. These properties
or a subset of themalso can be taken to fulfill the accuracy requirement described in 41. In this case the acceptance criteria
thus allow a maximum deviation of 0.05% for sensitivity, linearity, and eccentricity. Repeatability preferably is tested with a
test weight of a few percent of the balance capacity. At the lower end of its measurement range, the performance of laboratory balances is limited by the finite repeatability, and limitations induced by systematic deviations normally can be neglected.
Therefore, the whole weighing tolerance budget can be allocated to the acceptance criterion of the repeatability test.
For the sensitivity and linearity tests as described above, the analyst should use certified weights with an appropriate weight
class (e.g., according to International Organization of Legal Metrology R111 or American Society for Testing and Materials
E617, available from www.oiml.org and www.astm.org, respectively). [NOTEIf a differential method is used for the linearity
test, certified weights may not be required.]
Depending on the acceptance criterion, it may be sufficient to consider only the nominal weight value of the test weights. If
the nominal value of the test weight is considered, analysts should ensure that the maximum permissible error does not exceed one-third of the acceptance criterion. Alternatively, if the certified value of the test weight is considered, its calibration
uncertainty should not exceed one-third of the acceptance criterion. If more than one weight is used to perform the test, the
calibration uncertainties of the weights must be summed and the sum should not exceed one-third of the acceptance criterion. For tests such as eccentricity or repeatability, the use of certified weights is optional, but analysts must ensure that the
mass of the weight does not change during the test.
The tests described above also can be included in formal periodic calibration in order to fulfill applicable cGMP requirements.

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To facilitate handling, the test weight that is used for the repeatability test does not need to be at the minimum weight
value but can be larger because the standard deviation of repeatability is only a weak function of the test weight value.
In order to satisfy the required weighing tolerance, when samples are weighed the amount of sample mass (i.e., the net
weight) must be equal to or larger than the minimum weight. The minimum weight applies to the sample weight, not to the
tare or gross weight.
Factors that can influence repeatability while the balance is in use include:
1. The performance of the balance and thus the minimum weight can vary over time because of changing environmental
conditions.
2. Different operators may weigh differently on the balancei.e., the minimum weight determined by different operators
may be different.
3. The standard deviation of a finite number of replicate weighings is only an estimation of the true standard deviation,
which is unknown.
4. The determination of the minimum weight with a test weight may not be completely representative for the weighing application.
5. The tare vessel also may influence minimum weight because of the interaction of the environment with the surface of the
tare vessel.
For these reasons, when possible, weighings should be made at larger values than the minimum weight.

General Chapters

OPERATION OF THE ANALYTICAL BALANCE

Select the appropriate balance for the quantity and performance needed. General chapter 41 provides requirements for
balances used for materials that must be accurately weighed.The balance user should check the balance environment (vibration, air currents, and cleanliness) and status of calibration before use.

Receivers
To ensure suitable performance in measuring the weight of a specimen, analysts should consider selection of a proper receiver for the material.
General characteristics: All receivers must be clean, dry, and inert. The total weight of the receiver plus the specimen
must not exceed the maximum capacity of the balance. With a properly maintained and adjusted laboratory balance, weighing uncertainty for small samples, i.e., net weights with a mass not exceeding typically a few percent of the capacity of the
balance, essentially is determined by the repeatability. However, repeatability depends on the size and surface area of the
weighed object. For this reason large or heavy receivers introduce a deviation from the conditions under which the repeatability was determined without considering the receivers. Therefore, either receivers of a low mass and small surface should be
used (especially in cases when specimens of low weight are being measured) or the repeatability test should be performed
with the receiver placed on the weighing pan as a preload. Receivers should be constructed from nonmagnetic materials in
order to prevent magnetic interference with electronic balance components. Receivers should be used at ambient temperature
in order to prevent the formation of air currents within the weighing chamber.
Solid samples: Receivers for weighing solid materials include weighing paper, weighing dishes, weighing funnels, or enclosed vessels, including bottles, vials, and flasks. Hygroscopic papers are not recommended for weighing because they may
have a detrimental effect on the observed results.
Weighing dishes typically are constructed from a polymer or from aluminum. Antistatic weighing dishes are available for
measuring materials that retain static electricity. Weighing funnels typically are constructed from glass or from a polymer. The
design of this type of receiver combines attributes of a weighing dish and a transfer funnel, which can simplify the analytical
transfer of a weighed powder to a narrow-necked vessel such as a volumetric flask. For solid samples that are volatile or deliquescent, analysts must weigh the material into an enclosed vessel. Where practical, analysts should use an enclosed vessel
with a small opening in order to reduce sample weight loss from volatilization or weight gain from the adsorption and absorption of atmospheric water.
Liquid samples: Receivers for liquid samples typically are inert, enclosed vessels. For liquid samples that are volatile or deliquescent, analysts should use an enclosed vessel with a small opening, and the enclosure should be replaced rapidly following
material transfer. Special precautions should be taken to be certain that the receiver and the enclosure are constructed from a
material that is compatible with the liquid sample. The receiver and enclosure must have a seal that is sufficient to prevent
leaks from a liquid that is of low viscosity or has low surface tension or a low boiling point.

Types of Weighing
Weighing for quantitative analysis: The initial step for many quantitative analyses is to accurately weigh a specified
amount of a sample. Section 6.50.20 in the General Notices stipulates that solutions for quantitative measures must be prepared using accurately weighed analytes: i.e., analysts must use a balance that meets the criteria in 41. Errors introduced
during the weighing of a sample can affect the accuracy of all subsequent analytical measurements.

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General Information / 1251 Weighing on an Analytical Balance 1601

Addition weighing: Addition weighings typically are used for solid samples or liquid samples for which volatility is not an
issue. The receiver is placed on the balance. After the balance display stabilizes, the analyst should tare the balance; add the
desired amount of material to the receiver; allow the balance display to stabilize; record the weight; and quantitatively transfer
the material to an appropriate vessel or, if it cannot be guaranteed that the entire amount has been transferred, weigh the
receiver again and note the weight difference.
Dispense weighing: Dispense weighing typically is used for weighing emulsions or viscous liquids such as ointments. In
these situations it is not practical to weigh the material into a typical receiver. Accordingly, the analyst should tare the balance;
place the sample on the balance in a suitable container (e.g., a bottle, tube, transfer pipet, or syringe) that has been wiped
clean on the outside; record the weight after the balance display stabilizes; transfer the desired amount of sample to an appropriate receiving vessel, such as a volumetric flask; and place the pipet or syringe back onto the balance. The difference in the
two weighings is equal to the weight of the transferred specimen.
Gravimetric dosing: Gravimetric dosing typically is used for sample and standard preparations or capsule filling. For such
weighing the analyst places the volumetric flask, vial, or capsule shell on the balance; tares the balance after the balance display stabilizes; adds the solid or liquid components into the receiver by means of dosing units; and records the respective
weights.

Problem Samples

Safety Considerations When Weighing

During a weighing, the analyst may be exposed to high concentrations of a pure substance. The analyst must carefully consider this possibility at all times and should be familiar with the precautions described in the substances Material Safety Data
Sheet before weighing it. Hazardous materials should be handled in an enclosure that has appropriate air filtration. Many
toxicand possibly allergenicsubstances present as liquids or finely divided particles. When weighing these substances, analysts should use a mask that covers the nose and mouth to prevent any inhalation of the substance, and they should use gloves
to prevent any contact with the skin. [NOTEThe use of gloves is good practice for handling any chemical. If it is necessary to
handle the container being weighed, the analyst should wear gloves not only for self-protection but also to prevent moisture
and oils from being deposited on the weighed container.]

Official from May 1, 2015

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General Chapters

Electrically charged samples and receivers: Dry, finely divided powders may be charged with static electricity that can
make the powder either attracted to or repelled by the receiver or the balance, causing inaccurate weight measurements and
specimen loss during transfer. A drift in the balance readings should alert the operator to the possibility that the material has a
static charge. Commercially available balances with a built-in antistatic device can be used to remedy the problem. Such devices may use piezoelectric components or a very small amount of a radioactive element (typically polonium) to generate a
stream of ions that dissipate the static charge when passed over the powder being weighed. Antistatic weigh boats, antistatic
guns, and antistatic screens also are commercially available. The static charge depends also on the relative humidity of the
laboratory, which in turn depends on atmospheric conditions. Under certain conditions, static charge is caused by the type of
clothing worn by the operator and this charge can cause large errors in the weighing. Borosilicate glassware and plastic receivers have a well-known propensity for picking up static charge, especially at low relative humidity. The gloves used to protect
the operator also may increase the potential for a static charge problem. Placing the container in a metal holder may help to
shield the static charge, and antistatic gloves also can help to alleviate the problem.
Volatile samples: When weighing a liquid that has a low boiling point, analysts must receive the specimen in a vessel
with a gas-tight enclosure of small diameter. The analyst then tares the vessel and enclosure, adds the desired amount of sample, and replaces the enclosure. After the balance display stabilizes, the analyst records the specimen weight.
Warm or cool samples: Samples that are warm or cool should be equilibrated in the laboratory, or the weight readings
may be erroneous. With regard to warm samples, the apparent weight is smaller than the true weight because of heat convection. For example, a flask that is warmer than ambient air warms up this air, which then flows upward along the flask and
reduces the apparent weight of the contents by viscous friction.
Hygroscopic samples: Hygroscopic materials readily absorb moisture from the atmosphere and steadily gain weight if left
exposed. Therefore, hygroscopic samples must be either weighed promptly or placed in a vessel with a gas-tight enclosure.
For a gas-tight vessel, analysts should tare the vessel and enclosure, add the desired amount of sample, and replace the enclosure. After the balance display stabilizes, the analyst can record the specimen weight.
Aseptic or biohazardous samples: The weighing of sterile or biohazardous samples should take place within the confines
of a clean bench, biosafety cabinet, isolator, or similar containment device. Air flow within the hood potentially can cause balance instability, so after a balance has been installed under a hood, analysts should perform a rigorous qualification study with
suitable weight artifacts (see 41) in order to determine the acceptability of the balance performance in this environment.
Weighing corrosive materials: Many chemicals, such as salts, are corrosive, and materials of this nature should not be
spilled on the balance pan or inside the balance housing. Extra care is essential when materials of this nature are weighed.
Analysts should consider the use of sealed containers such as weighing bottles or syringes. In the event of a spill, requalification
of balance may be necessary, depending on the nature of the spill.

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1602 1265 Written Prescription Drug Information / General Information

USP 38

1265 WRITTEN PRESCRIPTION DRUG INFORMATIONGUIDELINES

The purpose of these guidelinescomprising format, content, and accessibility of prescription drug leafletsis to help ensure that leaflets are useful. In this context, useful means that recipients receive, understand, and are motivated to apply
written information about their medicines to achieve maximum benefit and minimize harm. Dispensers, prescribers, health
care providers who counsel patients about their medicines, and the patients themselves are intended to be the primary beneficiaries for these guidelines.

General Chapters

CRITERIA
(from the Keystone Action Plan1)
Written prescription medicine information should be based on the following criteria:
1. Scientifically accurate,
2. Unbiased in content and tone,
3. Sufficiently specific and comprehensive,
4. Presented in an understandable and legible format that is readily comprehensible to consumers,
5. Timely and up-to-date, and
6. Useful.

FORMAT GUIDELINES
1. Group all information from the same category, using brief, clear titles and bullets or subheadings as needed. Avoid symbols and subheadings not directly connected to the information they mark.
2. Be consistent in the placement and labeling of categories of information in all leaflets.
3. Provide information at the sixth-grade reading level or below, if possible (never above eighth-grade level). Do not exclude
information to achieve a lower reading level.
4. Use simple, common, accurate terms (for example, use noise in the ears, not tinnitus).
5. Use direct language that avoids words with opposite meanings (for example, use decrease blood pressure, not increase low blood pressure effect).
6. Provide reasons for instructions (for example, take with food to avoid upset stomach).
7. Emphasize the most important information. Clearly distinguish warnings from instructions or from other text that may be
misinterpreted as warnings.
8. Accompany each pictogram, if used, with corresponding text placed close to the pictogram. Use the simplest pictograms
possible. For pictograms intended to prompt patients to ask questions or inform health care providers, add text such as
Tell Doctor or Ask Pharmacist.
9. Make text readable by using 12-point or larger type, both uppercase and lowercase letters, an easy-to-read font (for example, a serif font), and adequate space between lines and paragraphs. To call attention to important information, use a
larger, boldface type.
10. Evaluate format by performing tests of readability, comprehension, memory, problem solving, and behavioral efficacy and
intention, using representative samples of the target population.

CONTENT GUIDELINES
1. Provide enough detail to facilitate correct use, achieve maximum benefit, and minimize harm, including a statement that
identifies activities (such as driving or sunbathing) that the patient should avoid.
2. Write text that is unbiased in content and tone and scientifically accurate. The uses described should be consistent with
FDA-approved labeling or otherwise permitted by FDA, or should appear in federally recognized drug compendia. Distinguish unlabeled from labeled use.
3. For drugs sold under a brand name, provide both brand and generic names, and include a pronunciation guide for each.
4. Describe the drug and its dosage form. Include indications and contraindications, specific directions for use, what to do if
a dose is missed, and what to do in the event of an overdose or poisoning.
5. Do not use abbreviations.
6. Indicate the intended type of benefit (for example, cure, prevention, to help relieve symptoms). Indicate howand
how soonthe patient should recognize the benefit and what to do if none is observed.
7. Give a balanced evaluation of risks and benefits.

1 In December 1996, the Action Plan for the Provision of Useful Prescription Medicine Information was presented to the Secretary of Health and Human
Services. The plan, commonly known as the Keystone Plan, described certain criteria for written prescription medicine information. These criteria are described in
detail in the action plan, which can be found at www.fda.gov/cder/offices/ods/keystone.pdf.

Official from May 1, 2015

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