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SYMBIOTE'C
PHARMALAB PVT. LIMITED
Formorly Known as Symbiolec Phorrnalab lid,
WORKING STANDARD
CERTIFICATE OF ANALYSIS

PRODUCT" ~. CLOBETASOL PROPIONATE PhEur

" ~,

BATCH No. WSCBP2302 DATE OF PREPARATION 25/01/2023

QUANTITY 40.0 9 VALID UPTO 24/01/2024
ARNo. WSCBP2302 DATE OF ANALYSIS 17/01/2023

S. Tost Result Speclflcation

No.
1. Characters
Appearance White, crystalline powder. White or almost white, crystalline powder.

Solubility Practically insoluble In water, Practically insoluble In water, freely soluble In

freely soluble in acetone, acetone, sparingly soluble in ethanol (96 per
sparingly soluble In ethanol cent).
-(96 oer cent).
2. Identification
IR Concordant IR Spectrum ot the sample dispersed, shall be
concordant with that of the reference
standard.
3. Specific optical rotation
at 20°C (1.0 % wlv +113· Belween +112" and +118· (dried substance)
sol'n In acetone)
4. Related substances
(By HPLC)
lmpurltv B BRL NMTO.3 %
Imouritv E Not detected NMTO.3%
Imouritv A BRL NMTO.2 %
Not detected,
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Impuritv 0 NMTO.2 %
Unspecified Imouritv 0.08 % 'NMTO.10%
Total impurities 0.3% NMT 1.0%
5. Loss on drying
(At 10S·C for 3 hrs.)
-. 0.3% NMT 0.5 % wlw
--=--
Sulph::.ted ash ~.Mu~
6.

S
0.05% NMTO.1 %w/w

~~.~
7. Assay On dried basis 99.7 % Between 97.0 % and 102.0 % W/w (dried
IIBv HPLC} On as is basis 99.4 % substance)
Oplnkm: The above material complies with the prescribed EP 11.0 specification,
Date of Completion: 25/01/2023 _r --=-
~1 <i ( , '1--?
(i;) ~
Prepared by
(A. Mehta) ~,');
Checked by ~
(V. Mahawar) ~y~11--l
Approved bf
(M. K. Mourya)

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