Form No.

: QC-F-002
SHINIL Pharma Ltd. Revision No. : 01
Revision Date: April 02, 2021
B.K Bari, Mirzapur, Gazipur. Ref. SOP No.: QC-SOP-004

Prepared by Checked by Approved by

(Officer, QC): (Sr. Officer, QC/QA): (Manager, QA):

Analytical Report of Raw Material (Active)

Material Name Ascorbic Acid (Vitamin C) BP Material Code RA-V08

Revision No. 00 Specification No. SPC-RA- V08
Effective Date July 02, 2022 Review Date July 01, 2025

GRN No. & Date Batch/ Lot No.

Manufacturer/Supplier
Name
Mfg. Date Exp. Date
QC Reference No. Sample Quantity
Sampled By Sampling date
Date of Analysis Retest Date
Test Results:
Sl. Parameters Specifications Result Tested
No. By
White or almost white, crystalline powder or
1. Appearance colourless crystals, becoming discoloured
on exposure to air and moisture
Identification
IR spectrum of the sample should
IR
concordant with that of reference standard
2. UV Must be complies as per BP
pH (5 % w/v
2.1 to 2.6
solution)
Identification A Must be complies as per BP
Freely soluble in water, sparingly soluble in
3. Solubility
ethanol (96 per cent).
4. Melting Point About 190 °C, with decomposition
Appearance of
5. The solution is clear and colorless
Solution
Specific Optical
6. + 20.5 to + 21.5
Rotation
Related Substance
Impurity Maximum 0.2 %
Impurities C & D Maximum 0.15 %
7. unspecified
Maximum 0.1 %
impurities
sum of impurities
Maximum 0.2 %
other than C and D
disregard limit Maximum 0.05 %

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 Form No. : QC-F-002
SHINIL Pharma Ltd. Revision No. : 01
Revision Date: April 02, 2021
B.K Bari, Mirzapur, Gazipur. Ref. SOP No.: QC-SOP-004

Prepared by Checked by Approved by

(Officer, QC): (Sr. Officer, QC/QA): (Manager, QA):

Analytical Report of Raw Material (Active)

8. Copper Maximum 5.0 ppm
9. Iron Maximum 2.0 ppm
10. Sulfated Ash Maximum 0.1 %
11. Assay 99.0 % to 100.5 % (As it is)
Comments:

Checked by: Approved by:

 PASSED Head of Department/Sr. Officer, QC Head of Quality Assurance

 REJECTED
Signature & Date Signature & Date

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