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TITLE Cilnidipine (WS) License No G/25/2046
‘CAS NO [132203-70-4] Batch No LF-WS/CILN/012023/001
Molecular Formula CyHasN207 Batch Size 250 kg.
Molecular Weight 492.52 g/mol Mfg. Date’ JAN 2023
HSN CODE 29333990 ‘Analysis Date | JAN 2023
Grade In-house : Retest Date DEC 2025)
Sr.No Test Parameter
Specifications
"Results
01 _| Description
Light yellow, crystalline powder.
Light yellow,
erystalline powder.
02 | Solubility
Very soluble in N-N-Dimethyl
acetamide; freely soluble in acetone;
sparingly soluble in methanol;
practically insoluble in water.
Complies
Identification
a. By IR
b. By HPLC
The transmission minima (absorption
maxima) in the spectrum obtained
with the substance to be examined
correspond in position and relative
size to those in the spectrum obtained
with the Cilnidipine working standard
The retention time of the major peak
| in the chromatogram of the sample
‘Complies
| Complies
Prepared by
QC Officer
Signature eat
Date
20)0112023Gel No : + 91- 99799 22299
+ 91- 99785 22203
! 0 | tele + 91 - 2692 - 233224
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CERTIFICATE OF ANALYSIS
TITLE Cilnidipine (WS) Ticense No | G/25/2046
Pca
CAS NO [132203-70-4] Batch No LF-WS/CILN/012023/001
Molecular Formula | CavHzsNzO> Batch Size | 250 kg
Molecular Weight 492.52 g/mol | Mfg. Date JAN 2023
| HSN CODE 29333990 ‘Analysis Date | JAN 2023
Grade In-house Retest Date
z |
[Sr.No Test Parameter ~ Specifications Results.
~T chromatogram of the standard
preparation, as obtained in Assay by
HPLC.
Melting Range 108°C to 113°C 109°C
Loss on drying Not more than 0.5% 0.20 % wiw
Heavy Metals ‘Not more than 20 ppm 12 ppm
‘Sulphated Ash ‘Noi more than 0.2% wiw 0.13 %wiw
Related Substances by
HPLC
Cilnidipine Impurity A | Not more than 0.15 % 0.07%
Any other impurity Not more than 0.10 % 0.06 %
Total impurity Not more than 0.3 % 0.19%
09 [ Assay (on the dry basis) | Not less than 98.0% to 102.0%. 99.81 % wiw
Remarks: The Batch is Complies / Boes-not complies as per above specific
CHE,
#3
] Prepared by | Checked by:
QC Officer QC Head ~
‘Signature si | i; Hy )
Das Bolotl2022 | 2oler!2o2