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Weizo DSR

This certificate of analysis summarizes quality control testing of a batch of WEIZO-DSR peridone prolonged release capsules. Key results: 1) All tested parameters including description, identification, average filled weight, uniformity, gastric resistance, dissolution, related substances, and assay were within specified limits. 2) The batch passed all tests and complies with quality standards. 3) The capsules contain the specified amounts of pantoprazole sodium and domperidone and should be stored below 25°C, protected from light and moisture.

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Ashish Sharma
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385 views1 page

Weizo DSR

This certificate of analysis summarizes quality control testing of a batch of WEIZO-DSR peridone prolonged release capsules. Key results: 1) All tested parameters including description, identification, average filled weight, uniformity, gastric resistance, dissolution, related substances, and assay were within specified limits. 2) The batch passed all tests and complies with quality standards. 3) The capsules contain the specified amounts of pantoprazole sodium and domperidone and should be stored below 25°C, protected from light and moisture.

Uploaded by

Ashish Sharma
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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ASSOCIATED BIOTECH

Quality Control Department


Certificate of Analysis
Product Name : WEIZO-DSR
peridone prolonged Release Capsules Ip
Batch i\umber : ACPD3002C A.R. No. : FPG0123073
Batch Size : 1.00 Lac Mfg. Date : JAN.2023
Qty. Sampled : 60 Caps. Exp. Date : D8C.2024
Receipt Date z 11.01.2023 Date
Released : 25.01.2023

Sr. No. Test Specification Result


I Descripfion Multi colour spherical pellets filled Multi coloured spherical
in light green colour cap & body of pellets filled in light green
hard gelatin capsule. coloured cap & body of hard
gelatin capsules.
2. Identification @y HPLC) In the assay, the retention time of
principal peak in chromatogram of
sample preparation corresponds to
that of standard preparation.
v' a
J. Average filled rveight 290.0 mg* 5.0%
Positive
289.9 mg
+,
A
Uniformity of filled weight t 10.0% of average filled weight -353%to +5.02%
5. Gastric resistance @y HpLC) NMT 10.0% dissolved in 0.1 M
( Pantoprazole) HCI -9.9%to9.lYo
6. Dissolution (By IIPLC)
Pantoprazole D. NLT 70.0% in phosphare buffer 94.4%to 108.2%o

Domperidone (SR) l'tHr. Between 15.0 %oto40.0oh 249% to 34.1o/o


4'r'Hr. Befween 30.0% to 65.0%o 40.1%to 58.2%
8th FIr. Between 55.O%to 85.0% 66.8% to76.3%
l2t' Hr.Not less than 7 0.0%o 84.7%to 94.8%o
7. Related Substances (By IIpLC)
For Pantoprazole
Any Secondary peak NMT 0.2% 0.03%
Impurity A NMT 0.5% Not detected
A- Impurity B NMT 0.3% Not detected
Impurity D&F NMT 0.75% Not detected
Sum ofall the secondary peak NMT 1.5% 0.06%
For Domperidone
Any Secontlary peak NMT 0.5% 0.40%
Sum qfall the secondary peak NMT 2.0% 0.85%
8. Assay (By IIPLC)
Each hard gelatin capsule contains:
Pantoprazole sodium Ip
(as sesquihydrate)
eq. to Pantoprazole 40 mg 36.0 mg to 44.0 mg 40.02 mg
(as enteric coated pellets)
Domperidone IP 30 nie 27.0 mgto 33.0 mg 30.39 mg
(as sustained release pellets)
;
(emarl{s Ihe above sample
ple comolfes/ ply with
omDlv w prescribed standard of qra@
to Store bel ow2 from light & moisture.
Analysed Bv Chgcked By i A-peroved By
Drgnalure

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