R{vIAN LIFESCIENCE pVT.LTD.pLOT.

NO_3,t, Sf, CTOR_8A,IIE,SIDCUL,

HARIDWAR-249403, UTTARA.KHAND
QUALITY CONTROL DEPARTMENT
CERTIFICATE OF ANALYSIS
Product Name
(;cneric Name
clib"n"lu.id" und Metfor.iffi
Glibenclamide and Metformin@
GBT't22012 Batch Size
Manufacturing Date
Sample Quantity l0 Tablets
Pharmaceuticals and Medical
Manufactured By Ravian Life Science P\,1. Ltd. Manufactured For Devices Bureau
oflndia
(PMBI)
Datc ofSampling 03.11.2022 03.1t.2022
Date ofAnalysis 03.11.2022
Ptck Size l0 x l0 Tablets Mfg. Lic. No.

Sr. No.

White coloured, roundihap{ White coloured- round

Description flat, scored on one side, shaped, flat, scored on one
uncoated tablets, side, uncoated tablets.
The principal peak in the The principal peak in the
chromatogram obtained with chromatogram obtained with
the test solution should be the test solution should be
Identitication
correspond to the principal peak conesponds to the principal
in the chromatogram obtained peak in the chromatogram
with the reference solution. obtained with the reference
solution.
Average weight 650mg+5% 651.03 mg
Unifbrmity of weight t 5 oZ
ofactual average weight - 0.69% to + 0.99%
5. Hardness NLT 3 Kg/cm 4.26 Kg/cm'. to'1.33 Ki,
6. Friability NMT I.O %
Dissolution Test
For Glibenclamide NLT 75 % (D) o/o
86.19 to 105 .98 o/o
For Metformin
Hydrochloride NLT 75 % (D) 99.47 o/o
to 101.99 o/o

Uniformity ofContent 85.0 % to 115.0 % ofaverage

(For Glibenclamide 96.48% to 100.22 %
Related Substances
For Glibenclamide Impurity A: NMT 1.0 %

Prepared By Checked Bv Approved By

Name Rustam Jai parkash Manoj Singh
Sign/Date

Designation
&dr/q"a---
Asst. Oflicer - QC
4-,,t-
Sr. Executive - QC
l)n\-{-
Manager - QC
-05
Prg€ No. I of2
iltL
l'roduct Name
RAVIAN LIFESCIENCE PVT.LTD.pLOT.NO-3j1, SECTOR-8A,IIE,SIDCUL,
HARJDWAR-249403, UTTAR {KHAND.
QUALITY CONTROL DEPARTMENT
CERTIFICATE OF ANALYSIS
Glibenclamide and Metformin Hydrochloride Tablets Ip (5 ms & 500
Ceneric Name Clibenclamide and Metformin Hydrochloride Tablets Ip (5 mg & 500rg)
GBTT22O12 Batch Size 7.50 Lac
Manufacturing Date l0/2022 Expiry Date 0912021
Stagc F'inished Sample Quantity 10 Tablets
Pharmaceuticals and Medical
Manufnctured By Ravian Life Science Pvt. Ltd. l\lanufartured For Devices Bueau oflndia
(PMBD
Dnte of Srmpling 03. r 1.2022 Report Date 03.11.2022
Date of Analysis 03.1t.2022 Sampled bl Dinesh
Pack Size l0 x l0 Tablets Mfg. Lic. No. 82NA/2007
llarket Domestic A.R. No. FPt22/3396

Any Single Impurity: NMT 0.2%

Total Impurities: NMT 0.5 70
For Metformin Single Impurity: NMT 0.1 %
Hydrochloride Total Impurities: NMT 0.5 %
Assay:-
Each uncoated tablet
contains:-
Glibenclamide IP 90.0 % ro |0.0 yo 5.06 me (101.I %)

90.0 % to 110.0 % 500.41 mg (100.2 %)

Remark: fhe above sarnple Complies as per IP Specification.

Prepared By Checked Bv Approved By

Namc Rustam Jai parkash Manoj Singh
Sigr/Date
?a,,&."-. -l-t,l*
Designatioll Asst. Oflicer - QC Sr. Executive - QC Manager - QC
lixnral N o : QC L/(r20/F0l-05
Pos. No.2 of2