Vlr'*LlfrEt_^&tsotseroruEs

(A Division of Anch pharmalabs Limitcd)

Foclory : vllloge Polhrerl, Bllospur . rouru Rood. Dlst. Gurugrom, Horyono - 122 413, lndlq
rel.: +?l -124-3581421/4au429. (M) 700241u65 webc[el **w.orihphormolqbc.com

CERTIFICATE OF ANALYSIS
No:1/2
Product Name: Atorvastatin Calcium USP
Product Code 14000914 Inspection Lot No. 040000217s1 l
Batch No. 3t42200103 Batch Size 91.100 KG
ManufacturingDate 4pr,2022 Expiry Date Mar,2027

Sr.No Tests Results Specification

I Description White crystalline powder White to off white
crystalline powder
2 Solubility Freely soluble in methanol, Soluble to freely soluble in
slightly soluble in alcohol, methanol, slightly soluble in
very slightly soluble in alcohol, insoluble to very
distilled water ,in pH 7.4 slightly soluble in distilled
phosphate buffer, and in water, in pH 7.4 phosphate
Acetonitrile; and insoluble buffer, and in Acetonitrile;
in aqueous solution of pH 4. insoluble in aqueous solution
of pH 4 and below.
J Identification
A. By IR Complies The Infrared absorption
spectrum of a potassium
bromide dispersion of the
sample must be concordant
with that of Atorvastatin
Calcium crystalline USP
reference /working standard.
B.By Calcium Complies The sample solution exhibits
a significant absorption at the
calcium emission line at
422.7 rcn.
4 Water (%wlw) (Method Ia) 4.6ohwlw 3.5o/owlw to 5.5% w/w
5 Enantiomeric purity (by HPLC) (% wlw) Not detected Not more than0.3o/owlw
(Atorvastatin related compound E)
6 Organic Impurities ( Procedure-2) (% w/w) (By HPLC)
Atorvastatin diamino 0.02 % (BDL) Not more than 0.15% ilw
Atorvastatin Related Compound A 0.03 % (BDL) Not more than 0.3% w/w
Atorvastatin Related Compound B 0.01% (BDL) Not more than 0.3% w/w
Atorvastatin Related Compound C Not detected Not more than 0.3% w/w
VERIFIED BY APPROVED BY

9*i^
(HOD-QC/DESIGNEE)
9du>
o -'1-
(HOD-QAi DESTGNEE)
-??*

Issue Datel.25.09.2023
Format No.:CQA0 45 lF 02-03

Corp. Ofice:503/505, Hyde Porlq Sqkl Vlhqr Rood, Opp. Anrq tndusHq! Erlote, Andherl (E), Mumbol .400 072, tndlo
leli +91-212-12871210lox +91-X2-42871285, Webrlle : www.orchphormotqbc.com
 Vlt'*lufrE ILAB otsATorufls
(A Division of Arch pharmalabs Limited)

- foclory: vllloge Pothred, Bllorpur. rouru Roqd, Dlrl. Gurugrom, Horyono .

lzl 413, lndlo
rel.: +rl -124-3581121/1,r1423 . (M) tog241u6s, websfieJ www.orchphormolobr.com

CLRTIFICATE OF ANALYSIS
No:212
Product Name: Atorvastatin Calcium USP
Product Code 14000914 Inspection Lot No. 0400002175r l
Batch No. 3t42200103 Batch Size 91.100 KG
Manufacturing Date Apr,2022 Expiry Date Mar,2027

Sr.No Tests Results Specification

Atorvastatin 3 2-enoic acid 0.01% DL Not more than 0.ljYo wlw

Atorvastatin Related H 0.05% Not more than 0.15% w/w
Atorvastatin epoxy tetra hydro furan Not detected Not more than 0.15% w/w

Atorvastatin ethyl ester Not detected Not more than 0.15% ilw
Atorvastatin Related Compound D 0.01% (BDL) Not more than 0.15% w/w
Atorvastatin Related Compound I Not detected Not more than 0.15% w/w
Any other individual impurity 0.06% Not more than 0.10o/o wlw
Total Impurities 0.tt% Not more than I .jYowlw
7 Assay (By HPLC) (% wlw on anhydrous 99.8 Yo w/w 98.0% w/w to l02.0ohwlw
and solvent free basis)
8 Residual solvents (By GC-HS) (ppm)
Methanol lNot detected Not more than 500 ppm
Ethyl acetate Not detected Not more than 2000 ppm
Methylene chloride Not detected Not more than 500 ppm
Tert-Butyl methyl ether (MTBE) 508 ppm Not more than 1500 ppm
Cyclohexane 4 ppm Not more than 700 ppm
Iso-propanol Not detected Not more than 700 ppm
Acetone Not detected Not more than 500 ppm
Tert-Butanol Not detected Not more than 100 ppm
Pivalic acid Not detected Not more than 100 ppm
Acetic Acid 33 ppm Not more than 1000 ppm
Additional Test :As per customer requirement
9 Particle size (By Malvern Mastersizer)
D(10) 0.47 pm NMT 5 pm
D(50) 3.61 pm NMT l0 pm
D(e0) 7.63 pm NMT 20 pm
Remarks: Material Complies as per above specifications. (D.C.No. FP/SPS/079-14)
BDL: Below Disregard Limit

VBRIFIED BY APPROVED
iieq- 7P '2-3
%'dY'@
(HOD-QC/DESIGNEE)
o
DESIGNEE)

Issue Datez 25.09.2023

Format No.:CQA0 45 E 02-03

Corp. Ofice:503/505. Hyde pork, Sokl Vlhor tood, Opp., Anso lndushlql
Eslote, Andhed (E), Mumbol _ 400 072, tndlo
lel:. +91'22'12871210 Fox +?1 -22-4287 1 285, Webrtte : www.orchphqrmolqbs.com