Unit 1, Pharmaceutcal Inorganic Chemistry, B Pharmacy 1st Sem, Carewell Pharma
Unit 1, Pharmaceutcal Inorganic Chemistry, B Pharmacy 1st Sem, Carewell Pharma
Unit 1, Pharmaceutcal Inorganic Chemistry, B Pharmacy 1st Sem, Carewell Pharma
© O INORGANIC
(lead
Phaymoceutic! (init typu
norqanjc) SCience) tor Syl PHARMACEUTICALS
preparation
oppr Nad
C
Histor labus:
ndtHeaVy
Chlorjda
chanistny
Sulphate
te of
(Impurities)
A
COmpounda
in for. Ipuritiea,
HU
of |ONIT-
whlch
(Acidifiers), norqanic
oF Chlorida
Phavmacopoia
of rd
R
(Eutiu)
Mutals,
dug L
slphat.
CHEMISTRY
It priniple
in
whch
E
,
Pharnaceuti
is Modified Sulphat
Sodium or sfudy 1"
mdicina 'involwe
th
Sourcul
invalved
W
obout
branch
BiCarbonak
,ron,
Antacids cal
it Scienca
in those
E Arsenie,
and CIQ
senl, in
test
thl of the
L L
PHARMACOPOEIA
(ommon
and Ihe publishad
U.sP)ek. of
(I-P about Cficial
qreek
Of
6.P by IF term
"oelia is sardocs
P
on
Govemnt.
book phaumacopoa
to be ward in do
thad sag.
H
q. Make defined
Inqiedients,
o opplicoble
Nom
ek. of whNch MaanA orms be
(ounty
peparotn
A
pharmakon'
Govemat.
definad
aa
dnugs as
Contoina and
to to
R
Coms
under
T pharmaceuticol
drugs
authorizd make"
depils as
IF is
-formulas ma from
conajn
information a th and
M
a
s}andard
quthority
"dnug" he book
a their
conplele (ON0qap
A
atda
of
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. • • • •
This
(940 INDIAN
C
Indian of
India.
L0. and It
overall
Indian PHARMACOPOE1A
pharmote
uwelfa,
is
and standardi
qof
A
fisHy Rule the
of of an
f Phama
Development (identit, qualiiy
Phamacopotìa approval drags
utical official
inist 1945. tho
R
Eovernmant
the (opola
at control
Drug products
E
tast
under (purity), documut
legaly
India
of is ond
ommission
(pharmoceutiala)
of ealth publishud
the and
W
Cosmetic (safehy
acaptable.
India,.
Copany assUronca
Second espon
and
E )
(IP) by and sible
fct
L L
pharmacopoeia RCOMMUndad
- - • India.
refesenca from
publishd publich After
NOu,
these Now,
academic SourCus,
Uses, ist It in ad
contain
(1955)ie. (885)
independenta, Bonqal
P
information
of tha
edition dosagt
sfondard
dugs Indian
and tets, first
institutions.
comitee
Monogaphs,
H
th pharmorO
th
severol
and edition
several
of formula lp phormacopoeia.
for publicahion
bnsially B.P.
elated
19sS.
Indian
A
soraga in
laboratoy
(1949)-tu
potia
afmmd uhich uas was
am oF
pharmacopoua
R
subsancuA
(onditions
Usd
by .
ontains IP developrd made
addendum IPC (
of
indushry
was 1P).
au a
Indian
M
: official pharmacopoeio
publishd
uas ete..
/suppnu
and
to
A
in
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C
• •1" EbITIONS
Ltdition 2
6thfdihon 3RD
8th 7h Gh
A
dition edition
fdithion dition
dition tdition
R
2014 Q007 YEAR
1946 1995 19S5
E
19
q 66
Ediion
INDIAN
W
AddendUm Addendum ADDENDUM
Addendum
Addend AddendUM
Supplement Supplement
AddendUm Adderdum Addendum AddenduM Addendum
2022.
E PHARMACOPOEIA
um
L
2005
2002 2000
2008 199! 1989
2019 ol6 2o1S 20R
I960 OR
1945
L
SUPPLEMENT
EDITIONS
P H
No.
3 2 3 2
4 3 3 Of
Volumes
A R
MONO
1149
220 52 271 261 890 986
GRAPHS
M
A
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subsfanca,
manuacturing
orisa ,
and piengs whjch
which salts
jdextified. by
C
"procs
inorqank idatified
also exci
impurities drg impurities
-product,
A
may
of basicaly
easil during eagents, eke..
ynthusis easil
sforag.
R
those
those
thosa
it by caaayst
not
producad
ae
, test.
E
ie. Mateial
: ae
-their Inpurities to
ae during related"
ak
impurities
inpurities ek. process.
.
Inpurities
These
impuritie
these
basiall
hu mefal
liat
during raus-
W
Fngnts Irorgaric
ba Ucing
drug-
cad hiovy
produ
Organic these
and
These om
EL
these
i) ii)
L
p
Substacas
toxicahy
and
of ek-
Phaamacoutical
qualihy
P
Impurities
types
) Iron,cloridu
pharacouticalA
(-foreign
TrPES
aue olution
H
thte
an
Unwanted t
AND
frsenic,
A
also
also cf
loues
SoURCES
in mainl
Inpurities Impuritie
R
pharmaceutiols
Impurities
Impuritie. Subrjuce
Ihorganic
|: ead, Residval
Of Orqonie
M
Impurities a Jnpuaihies
it They
-foreiqn Types
whih make
A
• e4
1) 11) 11)
O
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ocured
sourcUs raus
producs
Manufacture.
wich
impuvities
C
frorm
acidertally ek.
orious produt.
drug
matrial
siler
A
q,
manufacturi Sonetinu,
in from coppu,
in
IMPuRITI Souru in -Adulerotion
R
impurities USed end
or employed
azads ra
obainsd
excipiests elated lead,
Method
th
E
CÔmmon
Cotaminate
ng fiom
Nanufoctuing Materias
duri Materials
Of The Usad Envivonnt
Of
Accdeutal
be naterial,
or
W
ttocs
SoURCES may ProQSSU storog
aS MOst Dofect
Renqent
Such
E
Raw kuo
tho
vIn) V) 0
L
i) ii) ii) iv) v) v)
L
typu eke.
inpurities pur
proceus
i.e. of
impurities
distillatica
whjch Iprohibikel
furchond
method
teo in
io
Carbon
P
impurities
manufachuring
nto those
(etfet): those chamjcal
ateqorised
ie. thu steel.
stop substancu. %)
H
nethod
ae improves
those
ae bosIall than manufoctue
tneir by Thesa
A
These
-
hysjcal
: kMOved tmpurities
less
during
tnpurities
als0 Of basially
of fdding
R
which
Soluent: foncions
these Solvents. basis
may
and to
prodvcad
ba onstvuctive
substancu.
Destructive
which iron
M
May chomjally
Residual Impurties thu
tha
from
on
A
It
•
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iü) )
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Naß, inpurity
bodies, USe.
subfarcus
contomination
not emain
-
tery. toxict
occured
ond
prodvctsL to
we chapor . ynfit
C
insect of properties
chongk, efe
always subsancOS
.
which amnoUnt Cause
wSe taste
toxlc
and
at dust, wth
A
mrobial
inpurity odouv,
pysical unhuaienc
inpuities t mical
accidenty
Sonme
odulkakd a
pollute the active.
R
te. thun
Somtjmus, cf
conjaminaion,
Color,
sorage.
intabilitiy, f
eKCOs. t shelf-ufe
Somthm,, of
E
erro may phusical thuroapurticlly subsanc
omoUnt
is So effts
mixed maerial,
t
padking kBr
during ete.
Changes
choical in
W
Acidertol exponsve lite toxC
mal |cyoun. tu hu thu
aH present
Cross
storog making
anj A a Cawce aller make educs
nd
E May
(Vii) e in
(vii) is
L
manufocturing
impurities
ocUed
latim/exipients.
L
prodvct.
ek.
Hs,
inpusty aUSe ete
not ar
pH ocurs
- So, meallic
inpurities
impu may Gasel
sons peSSUR, erro.
ae oxidahon. tlundt
-
P
final manufacturing.
pecipitate
ials. during
Containation
thy solvent preducts.e
conguninohe Manufachuring
these qlau,
mater
.
manufactuing
formu Sonetims,
tenp. Overall
H
mixing,
oCus
atMosçhae,
f
murcuy Rsdue e
dirt,
procu.
eaguts h
A
to defects l.e.
improper
tinal
qros(eror)
and >
-
Hozavdy during
îno -frogments
Ouring elaled
Ammoniakd du to of
chemical
R
propavl from
in from ener
in to mixing
Contaminoton
bu du as
Used Dus Manufocturing
Evionmat
may oriso
ocCUS Processes
such
playtie
M
Rengort washad
to
Dafects to to
also due
e .It Ouu Due
A
• •
VD
iv)
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passed.
ofPassad
insolvbla
hlorida
of-failed masue
ldertifyinq
test which
C
is NO
solution
Soltion soluble +
lint solution is
which
A
and to
eacion,
budity
pRCipuatu
Agcl
Stordard for
than Turbudit
impuritie
with
test CHLORIDE
test
R
choridu
Tur used
HNO
soldion keoct
the
E
of basially acid. Nibrae
silver
torbidity ion on AqNO;
solution solution
cWorida) quarthity is
cf foR
standard of lvey
based nitric
nútrate
W
Turbdili
Torbiditi -foYm
TESt is
Stardakd I+
test
Principle is
the 4hair d.
thon
E LIMIT
It Stlwer whjch
th It
If in
L
• If, If, •
staudard solution
L
thiu,
impuritie basically
ldenhify substoncu.
- ck teut
Somi COde)
of
in
P
amount of
that
o ae
ae soltion.
to of cost
H
(dekermination)
te turbidt
Cylindes
standard
CoMpae
teats
Small Laghty
test inet the
Nessters
R
oR
thoco
control) on the
TESTS
quardilative
These
ak based with
compae
for
Împurities.
M
whjch
LIMIT
and Used
soluhion
These
is
A
Solution
Test
It we
•
.
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thun Control
vse uoUitie
mOe
thu
for soktion,
Stundard
soltion,
min.
for
in B le
asid
to
C
-& ady is
ylindu silve S
Som is
Culindr ud
sut soltion
solution
ard
sandard stand
A
and and
to Of
NeSsler Nessler
R
test of
1
of limet
obsemodon imt of turbidity
(onpare urbidiy
E
sol of
turbidity
the
Siver fo both
(AgNO3) the
A asida tubidit
in -A pAssel -faled
ylinder
linder
W
Som
|Set
thu
of h
NAHak
h
than Sample
Sarmple
to + im tu thon
Nessler
E Nessler
Duted
Add If
Teat
If
L
- -
L
qlinde, Nac.
SOUUT]ON
du compakd
teot (HNO3)
chJoridu(pp) tat -s) cworida
turbodii) thu
Nütole,
ylindes
MeasUring limi
P
pepar
on solution.
STANDARD
fer
appars which , Sama
to cylinder
Silver Afardard
acid,
Of
A
hove
is lorid), ee..
SOLÚTION
HNO2)
of rod
A)
- water
ylinder substanco
thjs, Ntic
formation Afandad
Glass D.
cf (
f :
M
10
• • O
• •
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wafer
which Salurotion Sulphat
prerenSypr)
SOLÚTION
so
sot" alohol as dist.
in w/ Barium
,
std. pesart
C
eaget tesf -) o.\0897. Hy m
sulphate-fte
fte te. Cylinder
4s
pepae
witth
witr - STANDARO
sulphae
tha(senstisl)of
A
of of
is sulphate in
Compared
Compared k,soy
(Nossler Sm
soluion. of Added
(Roch 2m
R
, to m
cloridu 1
haue of
ßaium
clorida
E
is Sulphaa
incHtase
Sandard watct
we phate
torbidit sulphae. SOLUTION
Barium -a)
Borium ths, spxified
of Cylindu sul Rarjum
m
W
:
-form y5
ProcadUHe cOf
potascivm In
covtajns, a
his this, Subsfanca Kagent
(Nessler
in
E well
TEST of of
Addual
tnen qm
1 S
L
In th
•
cortrlling
L
chlovida, u
qenat
make sulphát
so
ohich turbidity
0cdlc) in
wich
impurity
24
which
P
nd -for Aolvbl
usad except +
HNÔ, so
solution used in foum
HOction, Basoy
) di).(HI peipiatt
H
sulphale
add inpuritie bosially
wjth ppt
in
SULPHATE
jnsoluble
(Nitric
A
make
Heact
the
of HI
the sulphát
oher
R
is on
HNO, to is pHSence
BaCly
a foR idenhifying
based
Sod test dlorid
Rarium
dissolve thuy SubsfancL
TEST
+
di.
M
This c bidity 2
Soy
is is
cavte -turbid. Priniple:
jum th
Why forms
IF they LIMIT and It
bar
A
bi in tur
O
-
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problem
basically thesa
whjch coloed substonus test. which
C
ceoate
Convert during
problQms Solution.
pomanqonake). color
ke
for
SuLPHATES
A
foR
used an Colorle furbldty.
Somuims
purple
which duty
bidty. w
TEStS those
tut. test Cubstanu
R
basialy
tut, tubi
Into
tuts qives
limit (potassivm
overcomi
for tu
E
LIMIT AND becavee
limt in
Aubsfancas
clear
disturbana
Ubsfonce
those (olod of kunoy
CHLORIDE
during is
Modied
CHLORIDE
formation
Subsfancus,
W
MODIEIED
tet qu
KMnOy
ae to Colord)
These we this,
Bccurs (Hate
USed This (olored
These
foR
E
in So.
- in In
L
e
Jader. um solubion,
L
last Bacle
and m
of of
soluhon ssi ualet
of is
is n M (S pota
with solutjon
turbidity wighed ft o-s
ieagent
-for wafer. standard
s of (10om
P
keaguiSn)of
ith mixed
w/N solion
asida
to Rasoy teatcd
uplo
l0892.
of is test
is
H
the addad
sulphale of
usm wlt diluted
on.
Set chuck -fe of
oF solut
o. 0.0181%, turbidit
Ond sulphale
A
passed.
upto
of turbidit
s Sm wejghd
of Basoy al
HcI m
tuvaidty
R
hn Sond If
odd phalt.
dishiled to
Standotd
cuck alcchol
Oddad HCI, Result
less
Set then,
Test
thin
add
A
sul
•
•
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C
A
+
R E
SULPHATE
W
E
SULPHATE fOR TEST LIMIT
L
foR GRAM DIA RovaH
bath ethanol.
kMnOy turbjduly
+
L
2kOH
).
(chdoiot
substane
ol water a
etnan 24,0 for coloed
nognaium
of
of procadue
tet San
+ 97.
P
2Mnozt in above
qm on
HO inteofeono
with for cin
1S hat Of lit colorles
3H, (olorless
H
used
tea
Oissolve
usater, furthor
eOted
&
a
)
Redox rxn
m
also color
A
SOmo
CHtale
into
4 &dd 6o
sulphate
dist. follaus
ehonol)
: upto
29H,0H (purplu
is KMhOy
Reducing
is
R
ICMnoy
procadue
which
it
fet
ogut of Convert
dilue SULPHATE
Sõ
Conpound
AKMNOy
and al we
t, Purple
in
-hen fOR
.. liti
and So,
A
for Cool
. •
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diamte
quoytily
APPARATUS
tube diamser
sáde
2HU an qas papu,
arSenjc
dupnda Spying
clip qlass
uith solution through
intenal tor
C
t external
hole
(ftsHy),
stain) compod
long cWorida
GUTZEIT
sovtion colors.
A
200 6-5
Hq tet these
mruric
is
R
of A sfardod
staio qa
Chloridu) of
arsing
(Mecurlc
E
yellou) idensb
Hqch
to
of eachd
sfaun)
the
t
W
theso andenked
qas) Apparotus: tat.
wattr tube.
ftsH
CArsL yellow Rubbr Cork and
CNovidu
MOrcuric
2
Nou,
E paper
for During
for is the
which
hole
Hole exit
M
L
• (I in -
mercuric
ancs.
L
3H,0
is
whjch with
idertifying Stain.
state acid)
substancu.
and subs +
educhion
AsH,1 througn
P
arseneouS
ARSENIC
undesi SHn/H,
H
Rodschon
for acid. passed
in by aa
in
presut Reduchon
produce
tmpurities
purities the gas
A
hydrochloride
used known
GHho
qas
arsin Sud
-foR
on
R
is substanca 4 +
4 well based in rsin and
ocid)
cortolling
arsenc
ad)
TEST
fest into
HaftsOy paper
AsOz (Arsenedus
and (Arsenic
is Prináple:
is
M
COnverted is
Ibis harmful t
Arsenie
LIMIT firstl Hg chlorido
Zinc Then,
and
A
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Soktion
yelow in/ it.
passad.ReyulH
it
C
Heact A Aoe du
mjn. nl
imudiaedy
tut thun
papr stajn ef uith
A
qas b
the Ho /dianaer
in ,
Ahould washd
yelaw water
arsing sfain
Icaap -for
R
Hqc
conpord
intensity yellow
produu-
papr with
tut
E
0cide
wjth Sanding.
be
timit
Ahould thn
solution
corido
these
of ba
teoct
and infensit should
W
min. AST)
stajn lRss,han
:
PRautions
paper on tube
qas Compare
o tsonjc
auway
the 4o
yellow
E sfain
arsin Hqch tha H
lcaep -for IF
-
L
- •
Aolution KT
L
cubstanca.
chorida
SOLUmON
tu 3olution
of Zinc(AST)
KI
o on /qm
colors Snch
dependa sandard 1M
stannous
P
stain
sfain lodid)
present
stundard
STANDARO
in of of
presunt of
yellow (potasium
H
Intensity
sm
is arsonie
of of qM
sain
Add
impurities and Im Sm
1o
A
producus
x
yellous
test 4sTseu
paper. -heir qenerotor
ce prepaed chNorida
R
KT ot
/gm) Snclz
asendc
both
SoLUTION
qas of of opared 1M
Hey
chlorida
sfannous
Pepored zine
intnsity solution lodido)
indensit in wh
asin
M
Procedure:
of
of placed (S)
+ (potasiom
TEST
rcUrie botte
of
amoUnt and
Now,
-Test of qm
A
Add
Tu ahd
5
jo
- - •
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thioglyolic
water
Solufion ). m.
as SoLÚT|ON fee]. acid make
C
207. acaic upto
Stondard
iron to lkalin. 5
as diluted of kaep
aMMonia for each
(MerCopto
STANDARD
test solution
of drops
A
n. acd + (onpared
)
pepoed
o 2m Solution
Of (iron 2
Cihic
upto Add Add ake
R
Add acd
2 of
. • is
|
E
to thicglçoli
acid) color
w/u Make
ftee]
Soluion. in m. aside min
is t Sd
have SOLÜTTON discolved volume
207. acahie
ypto
Vo alkalina Developed
Ciron S
to keep
with
W
amnmonio solutn for
we of of (Nercopto
Stardard
acid diops
Procodue then
tirsHy. is up +
2m
TEST Solution
Sample
water
E
made 2
Add iric Make
acid Add
•Add
L
. .
acid]
24*
solution.
Color
L
idetifying
iron +
bufer, thoglycolate
0cehic a purple 00c HSHC
which is
of
(nerapto
P
in color
(oDelex
complex
inpurities
of
for citate
intensity
in purple
CO0
Used soluhion.
Iron
H
reochion aminonjum
acid thioglycolae
thioglycolae
«
is ivon this impurities
A
IRON colic
sjandard
test thiogly
the of
the Thioqlycolic
R
CHSH
fOR of intensity
with with
TEST based
forms olor. of +2
:
M
Tbs
•Principle react the CoMpared
Amount
LIMIT
and is the purple
which
TIhen 2fe Iron
A
It is in
In
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C=S
tn Soluion
color N=NN-NH
aád and
isted. „N=N.
is water
as ciric
ammonas
coplex solution
C
in uell funnel. AYogm) m)
violet
go
end
Dithizone-lead
as
color. NA-N,
A
Sample separcting átrote
test
is the Solutions.
Gmplex
udium
R
prepartd
aronium
at
alkalin
of
Compar
color
E
(le) quantity
both
dihzon
Pb ue solution, in
resulting +
first solution: of
Dithizone
transferred
we ,NHB 2SNEN
W
- knouun
lead
m
last
his, Sfandasd
.Procadure
the
E Test Add
and A
At
So In
L
i)
imMmedjakely
idertifying
L
solution.
(ditizon),
lead dithizon
od
then CNoroforM
test
compared which
solution,
P
of for in
diphenytiocarbazona
impurities
lead
color Used in colot.
reacion,
H
test.
standard
be form
io
should Colot
purple is
limü LEAD
A
test legd in
to
than the
solution ed in
of solution
R
If In It is in
•
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developad
ftee
seconds
lauer. f
test sfandard
mOHe HNÖ,
C
(1ead
is Pb
chlorofoam O. a
30 dil.
A
lead ptoceduk bt
layer ba
for in Should with
ot obfained
cNoroform
Solution
of
R
funnel.
should washd
solution Same
of /chemicolk
E
(color)
/Result:
seperahing )
sdution
Solution
color
th standad
th should
follow of
shake
reaqents
W
th caution:
Observaiorn
Sfandad color thh
cbserve a Nou, fest
Glqssuwa
Nou).
E n
The
than
Pre All
AI|
L
ii)
chlorofornm
n
tronsfer
L
and Gmmonia
ad %
% ma
discard
and
is add
cyanlde i
extrocts
and lo
soution of zong of
H
30ng
hydiochloride
unil
N ution solution
huylvoclor
ed adding
ithi
ditzon) and
potassjum 30
A
soluton
phunol dithizona sepavator. sol
combined
solutton dithjzone)
with acid
by
R
hytroxlamine
above
of
alkaline
o second seconds this
drops 5
the
the acd
md th Sandard
M
Combine in
2 solutión
Shako 4 Now,
extoct Ditje lauyer.
Nou,
Add Add
o 30
A
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solvto stadard(1eac)
3-4
solvtion Le. SOLUON in
solution Cylindes. ate
Mo watr buhuen
Stondord mlion'
dd.
bo
C
soluhon
nd
stondad
acid
not m 3S
standard adjustd
S Necsler
should DARD aetic
of per of upto
A
intensit as pats in ammonia
R
leod as
as pH by
vse thon usae•
solution
tet well
well
sampd
)woler
th lindy
beten
E
Compase
in /
sOLUTION
we soluhion.
expRssad acid
lead m
test test,
as of m cy
quartity Nosley
in(2s gatic
adjustcd SS
tect
foL :
W
ammonia
we ProceduR
upto
dissclued dil.
of this 20Dpm
Prepore TEST n
Nouw, is Specific 3-4)by
Color
Voluma
E ,so is
In It
• pH
in dil.
•
is
•
L
.
Zin(2n),
L
Calor.of
(Ha), acidic
is elk-. which
eoct
chenical
for it sulpkida 2H*
Concentaion,.
METALS Mercury
slver is /byoun
in Sulphidu
inpurities. t
densit reaction
(M) in
those chtomjUM
basiall
utal
(0), M,s
H
(Hs) eddish
HEAvY Cobal mtals
divn tal
are louw
mtallie
high ead (B),
A
(fs), Suphide
heavy torms fid'c
is Slpkad
thos at Cadnjum,
Aysenic
- based Mutaltydroqen
Hydroqen which
the Metals which of bs
TEST
Principle:
- solution
determining
li exomples is M+
Mdiym,
M
Heav ents ot
LIMIT This
toxjc) It
elem wth 2
a
A
• . •
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doesnot )ud
solution,(Na,s)Used.
Vsed.
:
qives qivea
thods
ths
solution,
which
C
who ,s which
substances,
otr CoMPLETED
solutin
A
substance
subsfancs
colorless
phama
by
R
b
colorles coloyles
Catuell
porformd
ormLd
those clear
hose
hose
E
UNIT-I
@
clear clear
for tor qive
for
W
also
A: R: C:
Mehod
Mathod
Mithod
is
EL L
in
freshly om D
CHydroqen S standard,
adiust is
Sfaudard
of tp olation
(HS
in
Volum |lceop produced
Sfandasd
adding test in
producad
1o Sulphide]
H
ptepaed Standard
Make
soluhions.
Color
by color
. in passed.
A
he produced
•
color
Conpake of
Son intensity
s nin both
R
than linit
kep
Observotion
adding
M
volu the
(Hydroqen
OTest
by •
•
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