This certificate of analysis provides test results for a batch of Cetrizine Ethanol CDH-1 (Impurity G) manufactured on July 22, 2014. Key details include: the material passed tests for appearance, solubility, identification by NMR and mass spectrometry, and purity of 99.69% by HPLC. The material is specified to be stored in an airtight container, protected from direct sunlight or refrigerated for longer storage.

1. CERTIFICATE OF ANALYSIS
CETRIZINE ETHANOL CDH-1(IMPURITY G)
Catlog code No
Product Name
Chemical Name
Mol. Formula
Mol. Weight
Batch No L1207NN Analysis Date
Quantity 50 mg Retest Date
Storage
S.N. Test
1 Appearance
2 Solubility
3 Identification by 1H NMR
4 Identification by Mass
5 Purity by HPLC
Remarks:
Sign.
Date:
FRM/007-00
Complies
Complies
99.69%
Based on 1H NMR, Mass and HPLC data, material confir
Prepared By
Preserve in Air tight container, protect from direct sunli
Result
off white solid
Freely Soluble in Me
N
N
Cl OH

2. 1032107
CETRIZINE ETHANOL CDH-1 (IMPURITY-G)
2-[4-[(RS)-(4-chlorophenyl)phenylmethyl]
piperazin-1-yl]ethanol,
C19H23ClN2O
330.85 g/mol
22-Jul-14
Jun-16
Approved by
Quality Control Department
confirms to the above product.
sunlight and for longer storage store at 2-8 C.
in Methanol