73 MecobalTablet

Table of Contents Page No.
01 02-03 04 05 06 06-09 09 Title Description
Table of Contents Release Specification Shelf life Specification General Information Method of Testing Method of Testing Method of Testing
Hardness, Friability, Loss on Drying, weight variation Identification, Assay of Mecobalamin Uniformity of Dosage Unit
Disintegration,
The Analytical Specification Contains All the Above Pages S.No 01. Nature of Change Update physical parameters of the tablets. Release Specifications DESCRIPTION: Core: Coated: HARDNESS: The average breaking test run on 10 tablets is not less than 3.0 Kp & not more than 12 Kp. FRIABILITY: (Ref : BP-2009) NMT 1% w/w LOSS ON DRYING: (IR Miosture Analyzer/Vacuum Oven) A White colored core circular tablet, having convex shape. A White colored, circular convex sugar coated tablet. Reason for Change To meet the current requirement
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1.0 - 3.5% (Granules) DISINTEGRATION: (Ref : BP-2009) Core Tablet: Coated Tablets: NMT 15 minutes NMT 60 Minutes
WEIGHT VARIATION: (Ref : BP-2009) Not more than two tablets deviate by more than 7.5% from the average weight based on the weight of individual 20 tablets. No tablet deviates by more than 7.5% from the average compression weight. IDENTIFICATION: (In-house Specification) (HPLC) 8. Positive for Mecobalamin
MECOBALAMIN 500 mcg/Tab. (BY HPLC) : (In-house Specification) Assay: NLT 475 mcg and (%L.S. 95% - 110%) NMT 550 mcg of Mecobalamin per tablet.
1. a.
UNIFORMITY OF DOSAGE UNITS: (Ref : USP-29, 2006) Each of 10 tablets contains NLT 85% & NMT 115% of label amount of claim content. Relative standard deviation: NMT 6% SHELF LIFE SPECIFICATION 1. DESCRIPTION: Coated: 2. HARDNESS: The average breaking test run on 10 tablets is not less than 3.0 Kp & not more than 12 Kp. 3. DISINTEGRATION: (Ref : BP-2009) Coated Tablets: - NMT 60 Minutes 4. Mecobalamin 500 mcg/Tab. (HPLC) : (In-house Specification) Assay: NLT 450 mcg and (%L.S. 90% - 110%) NMT 550 mcg of Mecobalamin per tablet. A White colored, circular convex sugar coated tablet.
b.
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General Information 1. Description: Core: Coated: A White colored core circular tablet, having convex shape. A White colored, circular convex sugar coated tablet
Core Tablets : Weight / Tablet : Weight of 10 tablets Hardness : Disintegration Time : Friability : Thickness: Diameter Coated Tablets : Weight of 10 tablets Hardness : Disintegration Time : Thickness: Diameter Label Claim per Tablet: Mecobalamin -------------------- 500 mcg Shelf Life: Overages Added: 2 Years 10 % To meet the specification of the requirement 3.0 - 12 KP NMT 60 minutes 4.0 0.2 mm 7.2 0.2 mm 113.9 mg 7.5% (105.4 122.4 mg) 1.139 2% (1.116 1.162 gm) 3.0 - 12 KP NMT 15 minutes NMT 1 % w/w 3.35 0.2 mm 6.4 0.1 mm
METHOD OF TESTING 1. Hardness: Determine the breaking point of each of 10 tablets and calculate the average hardness. 2. Friability: Proceed as per the SOP-10-QC-036 for friability (20 tablets) and record the results 3. Loss on Drying:
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Determine the record it. 1. Disintegration:
moisture
of
Granules
on
infrared
balance
at
105C
and
Proceed as directed in the SOP-10-QC-003 for Disintegration Test. 2. Weight Variation: Take 20 tablets from the composite sample for weight variation and record the results. 3. IDENTIFICATION: (In-house Specification) In the Assay test, the retention time of sample peak should match with the retention time of working standard peak. 7A. Assay of Mecobalamin in granules: (In-house Specification) a. b. Analyze six samples of granules by FTNIR collected from top, middle & bottom edges of container/s and record the % RSD (NMT 6%) The HPLC method given in section-7B may be followed under worst-case scenario.
7B.
Assay of Mecobalamin by HPLC Method: (In-house Specification) REAGENTS: Water Dibasic Sodium Phosphate Methanol Tartaric Acid. Distilled water Reagent Grade HPLC Grade Reagent Grade
Phosphate Buffer: Transfer 14.3 g of Dibasic sodium Phosphate into 1000 ml volumetric flask. Add 500 ml water to dissolve the contents & mix well. Make the volume up to the mark with the same solvent. Labeled this solution as A. Transfer 6 g of Tartaric acid into 1000 ml volumetric flask. Add 500 ml water to dissolve the contents & mix well. Make the volume up to the mark with the same solvent. Labeled this solution as B. Take 750 ml of solution A and add gradually solution B till the pH of the solution become 3.0. Mobile Phase: Mix 630 ml of phosphate buffer pH 3.0 & 370 ml of methanol. Stir for 15 minutes. Filter & degas the mobile phase at least for 20 minutes. Apparatus:
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HPLC Pump Degasser Auto Sampler Column Oven Detector Reporting System HPLC Column PARAMETERS: Injection Volume: Flow Rate Wavelength Temperature STANDARD PREPARATION:
Agilent 1100 Series Agilent 1100 Series Agilent 1100 Series Or Equivalent Agilent 1100 Series Agilent 1100 Series Agilent 1100 Series Reversed Phase, Stainless steel column, (Nucleosil C18, 5 4.6 mm ID x 250 mm ), 20 l 1.0 ml/minute 264 nm 40C
Transfer accurately weigh 100 mg of Mecobalamin working standard in 100ml volumetric. Add 50 ml of water to dissolve. Mix well & make the volume up to the mark with same solvent. Pipette out 6 ml of the resulting solution & add 6 ml of distilled water in a 100 ml volumetric flask. Add mobile phase to make volume to 100 ml and mix well. Filter a portion through 0.45 syringe filter and then degas by sonicator. SAMPLE PREPARATION: I. tablet. II. III. IV. V. VI. VII. system. Weigh accurately 12 tablets and determine the average weight of one Transfer it into a 100 ml volumetric flask. Add 12 ml water and disintegrate tablets by sonications. Add mobile phase to make up volume to 100 ml. Stir this solution with magnetic stirrer for 5 minutes. Allow to stand for 10 minutes. Filter a portion through 0.45 syringe filter and then inject into the SYSTEM SUITABILITY: I. Inject five replicate injections of the standard solution and calculate the percent RSD (NMT 2%). II. Or Set the operating condition and purge the mobile phase until a steady base line is obtained. III. Inject working standard solution of Mecobalamin onto the column and obtain the chromatogram. IV. From Chromatogram, calculate the tailing factor/or resolution factor if required (Tailing factor: NMT 2 & NLT 1 is recommended) HPLC PROCEDURE: i. ii. Flush the column with water at a flow rate of 1.0 ml for at least 30 minutes. Set the conditions outlined under parameters.
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iii. iv. v.
Equilibrate the column with mobile phase until a steady baseline is obtained. After the column is equilibrated, inject the standard and sample solutions. At the end of the analysis, again flush the column with mobile phase for 20 minutes followed by water for 30 minutes and then with methanol for additional 30 minutes.
Calculation: Spl. Peak Area Std wt. (mg) 6 100 mg of Mecobalamin / Tab = ------------------ x ---------------- x ------ x %Purity x -------------- x Tab. Avg. Wt. (g) Std. Peak Area 100 100 Spl wt. (g) mg of Mecobalamin / Tab % Assay = ----------------------------------------- x 100 Label Claim 8. UNIFORMITY OF DOSAGE UNIT: (In-house Specification) Proceed as directed in section-7B using single core tablet with appropriate dilutions for uniformity of dosage unit (10 samples) instead of composite sample.
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Table of Contents Page No.

01 02-03 04 05 06 06-09 09 Title Description

Controlled When in Red

Controlled When in Red

Controlled When in Red

Determine the record it. 1. Disintegration:

Controlled When in Red

Controlled When in Red

Controlled When in Red

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