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Unit 1, Pharmaceutcal Inorganic Chemistry, B Pharmacy 1st Sem, Carewell Pharma
Unit 1, Pharmaceutcal Inorganic Chemistry, B Pharmacy 1st Sem, Carewell Pharma
©
C (lead
O INORGANIC
(init typu
norqanjc) SCience)
Phaymoceutic!
Sulphate
chanistny
Chlorjda
te of
in for.
(Impurities)
HU COmpounda Ipuritiea,
whlch
of |ONIT-
(Acidifiers),
oF
of norqanic
rd Chlorida
Phavmacopoia
(Eutiu)
E
Mutals,
dug slphat.
L
It in CHEMISTRY
whch , priniple
W
is Pharnaceuti
Sodium or sfudy
Modified Sulphat
1"
mdicina 'involwe
th
Sourcul
,ron, invalved
EL
obout
branch
BiCarbonak
cal
Antacids
it Scienca
in those
and CIQ
test
Arsenie,
senl, in
thl of the
L
PHARMACOPOEIA
and Ihe
of publishad
(ommon
PH
U.sP)ek.
(I-P about Cficial
qreek
Of
6.P by IF
on "oelia
term
is sardocs
Govemnt.
thad
to book
be ward phaumacopoa
in do
sag.
q. Make o
AR
defined opplicoble
Inqiedients,
Nom
ek. of whNch MaanA orms be
(ounty
peparotn
aa pharmakon'
Govemat.
definad
dnugs as
Contoina
to and to
Coms
under
M
T drugs
as
pharmaceuticol
authorizd make"
depils
IF is
ma from
-formulas
conajn
information a th and
a
A
s}andard
quthority
a
"dnug" he their
book
conplele (ON0qap
atda
of
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. C • • •
This
•
is
and standardi uwelfa,
qof
fisHy Rule
of of the an
Development
f Phama
(identit, qualiiy
Phamacopotìa approval drags
official
inist 1945. tho utical
the Eovernmant
E
(opola
at control
Drug products
tast
W
under (purity), documut
legaly
India
of is ond
of ealth
ommission
publishud
the
(pharmoceutiala)
and
EL
India,. Cosmetic (safehy
acaptable.
Copany assUronca
Second espon
and
)
(IP) by and
fct sible
L
refesenca
- - • pharmacopoeia
India.
from
RCOMMUndad
publishd
these publich After
ist It
NOu, Now,
ad
PH
SourCus,
academic
Uses, in
contain
(1955)ie. (885)
edition information
dosagt
of tha independenta, Bonqal
sfondard
dugs Indian
and tets, first
institutions.
Monogaphs,
comitee
th th
AR
pharmorO
and edition
severol
several
of for formula lp phormacopoeia.
publicahion
bnsially B.P.
elated
19sS.
Indian
laboratoy
soraga in
potia
uas
.
(1949)-tu
uhich was
afmmd
am oF
pharmacopoua
subsancuA
by
M
Usd (onditions
was 1P).
indushry
au a
: Indian official pharmacopoeio
A
publishd
uas ete..
/suppnu
and
to
in
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C
AR
• •1" EbITIONS
2
6thfdihon
Gh Ltdition 3RD
8th 7h
dition edition
dition
fdithion
dition tdition
E
Q007
2014 1946 1995 19S5 YEAR
19
W
q 66
Ediion
INDIAN
EL
AddendUm Addendum ADDENDUM
Addendum
Addend AddendUM
Supplement Supplement
AddendUm Adderdum Addendum AddenduM Addendum
2022.
PHARMACOPOEIA
um
2005
L
2002 2000
199! 1989
2019 ol6 2o1S 20R 2008
I960 OR
1945
SUPPLEMENT
PH
EDITIONS
AR
No.
3 2 3 2 Of
4 3 3
Volumes
M
MONO
1149
220 52 271 261 890 986
GRAPHS
A
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subsfanca,
C
orisa manuacturing
,
which and piengs whjch salts
jdextified. by
"procs
AR
inorqank
also exci idatified
-product,
may
of basicaly
easil during eagents, eke..
ynthusis easil
sforag. those
those
thosa
E
it by caaayst
not
ae ie.
, :
producad
test.
. ae to
W
Mateial
ae during
-their
related"
ak Inpurities
impurities
inpurities ek. liat
Inpurities
impuritie
these process.
hu mefal
These basiall
during raus-
ba
EL
Fngnts Ucing
drug- Irorgaric
cad hiovy
produ
Organic these
and
These om these
ii)
L
i)
p
Substacas
toxicahy
PH
and
of ek-
Phaamacoutical
qualihy types
) Impurities
Iron,cloridu
pharacouticalA
TrPES
(-foreign
aue olution
thte
AR
an
Unwanted t
AND
loues
also
also
frsenic,
cf
SoURCES
in mainl
Inpurities Impuritie
present impue)
may
ad Impuritie
M
ae alcjum,
Solven
pharmaceutiols
Impurities
|: Impuritie. Subrjuce
ead, Of Ihorganic
it
Residval
Orqonie
Impurities a They
A
Jnpuaihies
-foreiqn Types
whih make
• e4
1) 11) 11)
O
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ocured
C sourcUs raus
producs
Manufacture.
wich
impuvities
frorm
ek.
AR
acidertally
orious produt.
drug
siler
q, matrial
manufacturi Sonetinu,
in
in from
in
coppu,
IMPuRITI
impurities
Souru
USed -Adulerotion end
E
or employed
obainsd
azads ra
excipiests
Method elated th lead,
W
ng CÔmmon
Nanufoctuing Materias
fiom Cotaminate
duri
Of The
Materials
Usad Of
be naterial,
or Envivonnt
Accdeutal
ttocs
EL
SoURCES may ProQSSU storog
aS MOst Dofect
Renqent
typu eke.
i.e. inpurities
of pur
proceus impurities
distillatica
PH
whjch Iprohibikel
furchond
teo method
io
in
Carbon
impurities
manufachuring
nto those
(etfet): those chamjcal
ateqorised stop
ie. thu %) steel.
substancu.
nethod
AR
ae
those
ae bosIall
improves
than manufoctue
tneir
These
by - Thesa
hysjcal
: kMOved tmpurities
less
during
tnpurities
als0 of Of basially
fdding
which
M
Soluent: foncions
these Solvents. basis
may
and to
prodvcad
ba onstvuctive
substancu.
Destructive
which iron
Impurties thu May chomjally
A
Residual
tha
from
iü)
on
It
• )
€
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bodies,
Naß, inpurity
- USe.
C subfarcus
not emain
contomination
we chapor . ynfit
insect chongk, of properties
efe
AR
always subsancOS
which wSe
Cause
amnoUnt
taste
toxlc
at dust, wth
and
mrobial
inpurity odouv,
inpuities t pysical mical
unhuaienc
accidenty
Sonme
pollute
odulkakd
the a
active.
te. thun
cf
E
Somtjmus,
conjaminaion,
Color,
sorage.
intabilitiy, f
erro
Somthm,,
may
of eKCOs. t
phusical thuroapurticlly
shelf-ufe
subsanc
W
is
omoUnt
So effts
mixed maerial,
t
padking
during kBr
ete.
Changes
choical in
lite
Acidertol exponsve toxC
tu hu
EL
Cross
mal aH |cyoun.
present thu
storog
nd anj A a Cawce aller make educs
making
May
(Vii) e in
(vii) is
L
manufocturing
impurities
latim/exipients.
ocUed
ek.
Hs,
prodvct. inpusty ete
not
aUSe
ar
- So,
.
PH
pH ocurs
meallic
inpurities
impu
ae final
- sons oxidahon.
may Gasel
tlundt peSSUR,
manufacturing.
erro.
pecipitate
ials. during
thy solvent
these
preducts.e
Containation
conguninohe Manufachuring
mater qlau,
formu Sonetims,
Overall
manufactuing
tenp. mixing,
AR
oCus
f atMosçhae,
murcuy Rsdue e
dirt,
procu.
eaguts h
to defects l.e.
and >
tinal improper
- during
qros(eror)
îno Hozavdy
Ammoniakd
Ouring
du to chemical
elaled of -frogments
in from
M
propavl
in to
from ener bu du Contaminoton as
mixing
Evionmat
may oriso
ocCUS such
Processes
to playtie
Rengort to to
A
washad Dafects
also due
e .It Ouu Due
• •
VD
iv)
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passed.
ofPassad
C insolvbla
hlorida
of-failed masue
ldertifyinq
test which
is NO
AR
solution
+
Soltion
lint solution
soluble
is
and to which
budity eacion,
Agcl
for
pRCipuatu
Stordard
than Turbudit
with
impuritie
test test CHLORIDE
choridu
Tur used
E
HNO
soldion keoct
the
of basially acid.
W
Nibrae
silver
torbidity ion on AqNO;
solution solution
quarthity
based
is
nitric
lvey
nútrate
Turbdili
Torbiditi
EL
-foYm
test Stardakd
TESt is I+
the
It 4hair
Principle is
Stlwer whjch
d.
thon LIMIT
th It
If
• If, If, in
L
staudard solution
thiu,
basically
-
impuritie
ck teut
PH
ldenhify substoncu.
Somi COde)
of
in
amount of
that
o
to of ae
ae cost soltion.
quavtitatie qvatity
in
AR
principle
/opales
desiqnud
which fo
pesont
of teut
(dekermination)
te ffurbidit,
Cylindes
turbidt
standard
CoMpae
teats
Small
test
Laghty inet the
oR Nessters
M
thoco
control) on the
TESTS
quardilative
These
ak based with
for compae
Împurities.
A
whjch
LIMIT
and Used
These
is soluhion
It we
Solution
. Test
•
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thun
vse thu Control
uoUitie
C for
mOe
soktion,
Stundard
min. le soltion,
for
in B
asid
-& to
ady is
AR
ylindu silve S
Som
Culindr is ud
sut soltion
ard
solution
sandard stand
and and
to Of
NeSsler Nessler
Dilujed
tet test teat
test of
E
1
of limet
obsemodon imt of turbidity
(onpare urbidiy
sol of
W
turbidity
the
Siver
(AgNO3)
fo both
the
A asida tubidit
in ylinder
-A pAssel -faled
Som linder
thu
EL
of |Set h
to Nessler
+ im NAHak
Nessler
tu thon Sarmple
h
than Sample
Duted
Add
Teat
If If
- -
L
qlinde, Nac.
du compakd
SOUUT]ON
tat
PH
teot
turbodii)
chJoridu(pp)
Nütole,
ylindes
MeasUring limi
on pepar
solution.
STANDARD
appars which
to cylinder
Sama
Silver acid,
hove
Afardard
Of
is lorid), ee..
rod
thjs,
-
ylinder substanco
water
Ntic
formation Afandad
Glass D.
cf (
f :
tes for :
+ of
aMount Procdure Appadus TEST
of
A
(Nessles
Chemials
Specified
Degee
Nou,
with
to 10
Jm
• • O
• •
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wafer
which Sulphat
prerenSypr)
Salurotion
so
sot"
C SOLÚTION
alohol as dist.
in
, w/ Barium
std. pesart
eaget tesf -) Hy m
AR
o.\0897.
fte
sulphate-fte
te. Cylinder
4s
witth
witr -
sulphae
pepae
STANDARO
tha(senstisl)of of of
is sulphate in
Compared
Compared k,soy
(Nossler
of Added
Sm
soluion.
(Roch 2m
, to m
E
cloridu
ßaium
haue 1
of
clorida
is
W
Sulphaa
Sandard watct
incHtase
we phate
torbidit
Barium
sulphae. SOLUTION
-a)
Borium ths, spxified
of Cylindu sul m Rarjum
EL
:
-form
cOf y5
potascivm
ProcadUHe
In a
his this,
covtajns,
Subsfanca
in Kagent
well
TEST
(Nessler
of of
tnen qm Addual
In th 1 S
L
cortrlling
chlovida, u
qenat
so make sulphát
PH
ohich turbidity
0cdlc) in
impurity
wich
24
nd -for Aolvbl
which
usad except +
solution
HNÔ,
used in so foum
HOction, Basoy
) di).(HI peipiatt
AR
sulphale
add inpuritie bosially
wjth ppt
in
SULPHATE
jnsoluble
(Nitric
make
Heact
the
of HI
the sulphát
oher
is on
to is
M
HNO, pHSence
BaCly
a foR idenhifying
based
Sod test dlorid
Rarium
dissolve thuy SubsfancL
+
di. TEST
This c bidity 2
Soy
A
is is
Why
cavte -turbid. Priniple:
jum th
IF they LIMIT and It forms
bi bar in tur
O
-
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problem
C basically thesa
whjch coloed substonus test. which
ceoate
AR
Convert during
problQms Solution.
ke
for pomanqonake). color
foR
an
SuLPHATES
overcomi
limit
for tu limt
(potassivm
in
W
LIMIT AND becavee
Aubsfancas
clear
disturbana
those
CHLORIDE
Ubsfonce
(olod of kunoy
during is
Modied
CHLORIDE
formation
tet Subsfancus,
qu
EL
MODIEIED KMnOy
ae to Colord)
These we this,
Bccurs
USed This (olored
(Hate
These
foR
in So.
- in In
e
L
Jader. um
of of last Bacle
solubion,
is n M
turbidity wighed
ieagent
ft o-s with solutjon
-for wafer.
s
ith keaguiSn)of
mixed
of (10om
standard
w/N solion
asida
to Rasoy teatcd
uplo
test
the is l0892.
of is
AR
sulphale
addad
usm wlt of
on. diluted
Set chuck o. -fe of
oF solut Ond sulphale
0.0181%, turbidit
passed.
upto
s Sm of turbidit
of wejghd
Basoy al
tuvaidty
1gm
HcI
then th m
and(Sn)of these
M
1
pepae of the tet
for waler,
- dilute
- soluion s
oF 20m
thun
the
asede solution kgsOy than
limit
the hn Sond If
to odd phalt.
A
dishiled
cuck Standotd
alcchol
less
Oddad HCI, Result
Set then,
thin
Test add sul
•
•
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C Standad sa
sah Tet
4)
AR
+
E W
SULPHATE
EL
2kOH
).
ol water
for a
(chdoiot
substane
of
PH
+
2Mnozt qm on
97. in above
HO
lit
inteofeono
with for cin
1S hat Of colorles
3H, (olorless
used
tea
AR
Oissolve
usater, furthor
eOted
&
a
)
Redox rxn
m
also color
SOmo
CHtale
into
4 &dd 6o
sulphate
: dist. follaus
upto
is 29H,0H ehonol)
KMhOy
is (purplu
Reducing
procadue
it
M
which
ICMnoy
fet
ogut of dilue SULPHATE
Convert
Conpound
t, AKMNOy
and al we
Purple
in
and
-hen fOR
.. So, liti
.
for
•
Cool
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diamte
quoytily
tube APPARATUS
sáde
an
2HU
C arSenjc
diamser
qas papu,
dupnda Spying
clip qlass
uith tor solution through
intenal
t external
AR
hole
(ftsHy),
stain) compod
long cWorida
GUTZEIT
sovtion colors.
200 6-5
Hq tet these
mruric
is
of A
E
sfardod
staio qa
Chloridu) of
arsing
(Mecurlc
W
idensb
Hqch yellou)
to
of eachd
sfaun)
the
t
theso
EL
qas) Apparotus:
andenked
tat.
wattr
ftsH tube.
CArsL yellow Rubbr Cork and
CNovidu
MOrcuric
Nou, paper
for During
2
for is the
which
hole
Hole exit
•
M
in -
L
(I
mercuric
ancs.
3H,0
is
whjch with Stain.
PH
idertifying
state acid)
substancu.
and subs +
educhion
AsH,1 througn
adicine in ad ((ArseneoUS
(AYsina) yellow
rable eaction, HftsOz
arseneouS
ARSENIC
undesi SHn/H,
for
AR
acid. Rodschon
in by passed
aa
in
presut Reduchon
used purities
tmpurities the gas hydrochloride
produce
known
GHho
qas
arsin
-foR
on Sud
is
in +
M
substanca 4
4 well based
ocid)
rsin and
cortolling
arsenc
ad)
TEST
fest into
HaftsOy paper
AsOz
is and (Arsenic
(Arsenedus
is Prináple:
Ibis is
A
COnverted
harmful t
Arsenie
LIMIT firstl Hg chlorido
Zinc Then,
and
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tut imudiaedy
thun
papr stajn ef uith
qas
the Ho b
/dianaer
in
Ahould washd
,
yelaw water
Icaap -for arsing sfain
Hqc
E
conpord
intensity yellow
produu-
papr
tut with
0cide
be
W
wjth Sanding.
timit
Ahould thn
solution
these
of ba corido
teoct
and infensit should
min. AST)
EL
stajn lRss,han
:
paper
PRautions
on tube
o
qas Compare
tsonjc
the 4o auway
yellow sfain
tha
lcaep -for
arsin Hqch
IF H
- -
•
L
cubstanca.
Aolution KT
tu 3olution SOLUmON
of
chorida
Zinc(AST)
PH
KI
o on colors
/qm
Snch
dependa sandard 1M
stannous
stain
sfain lodid)
present
stundard
in of
STANDARO
of
presunt of
yellow
sm (potasium
is
AR
Intensity
arsonie
of of qM
sain
Add
Im Sm
impurities and 1o
producus
x
yellous
test 4sTseu
paper.
ce -heir
prepaed qenerotor
KT ot chNorida
Snclz
M
both
/gm)
asendc SoLUTION
qas of of opared
Hey 1M
chlorida
Pepored
lodido)
sfannous
zine
asin
intnsity
indensit
solution
in wh
of
Procedure:
of (S)
A
placed
+
rcUrie
amoUnt and
TEST
botte
(potasiom
of
Now,
-Test
Add
of qm
Tu ahd
- jo
- •
5
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thioglyolic
water
). m.
C as Solufion
make
SoLÚT|ON fee]. acid
uel w/ and aside Mn
with 50 other
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based
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the
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It is In
in
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C=S
tn Soluion
C
color N=NN-NH
aád and
isted. „N=N.
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at aronium
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lead
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impurities
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be
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standard
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purple is
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to
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M
minutes.
on
intensity (less) passed is
controling
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is thic,
A
the Salution
Sample
LIMIT
is
complex
and
If In It is in
•
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Solution
of cNoroform
obfained
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funnel.
should washd
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ution solution
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A
2 solutión
Shako 4 Now,
extoct Ditje lauyer.
Nou,
Add Add
o 30
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solvto stadard(1eac)
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solution
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ot
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ents
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elem 2
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doesnot )ud
:
C Vsed.
solution,(Na,s)Used.
qives qivea
thods
ths
solution,
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Solution
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adding
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•
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