CERTIFICATE OF ANALYSIS FQA 09/02/27.03.

2014
Product Name METFORMIN HYDROCHLORIDE USP
Batch No. 2022MPC0318 Mfg. Date July 2022
Batch Quantity 2000 kg Exp. Date June 2027
Qty supplied 2000 kg Date of Analysis 15.07.2022
A. R. No. AMPC/22/0318 Released Date 15.07.2022
Sr.No TEST SPECIFICATION RESULT
1. Description White crystalline powder White crystalline powder
2. Solubility Freely soluble in water, slightly Freely soluble in water,
soluble in ethanol, practically slightly soluble in ethanol,
insoluble in acetone and in practically insoluble in
methylene chloride. acetone and in methylene
chloride.
3. Identification:
a. By IR IR Spectra of sample is Complies
concordance with working std
b. Reaction of chloride Gives positive reaction of Complies
chlorides.
4. Related substances (By HPLC)
a) Metformin related compound A Not more than 0.02 % 0.008 %
b) Any other impurity Not more than 0.1 % 0.038 %
c) Total Impurities Not more than 0.5 % 0.062 %
5. Heavy metals Not more than 10 ppm Less than 10 ppm
6. Residue on ignition Not more than 0.1 % 0.05 %
7. Loss on drying Not more than 0.5 % 0.17 %
(At 105 0C for 5 hrs)
8. Assay on dried basis Not less than 98.5 % and not 99.70 %
more than101.0 % on dried
basis
Additional test:
1. Particle Size 90% particles should be pass Complies
through 100 mesh
2. Residual solvents Not more than 1000 ppm 34 ppm
Methanol
3. Nitrosodimethylamine (NDMA) Not more than 30 ppb 3.14 ppb
Remarks: The sample complies with prescribed standards of USP specification.
Declaration: Product is free from animal derived material & manufactured from synthetic source only.
Analysed by Checked by Approved by
NAME Zarina Churi P.B.Galave K.S.Kulkarni

Sign

DATE 15.07.2022 15.07.2022 15.07.2022