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FP Spec.

The document specifies the finished product requirements for Roximax 500 Tablet, an antibiotic manufactured by Veritas Pharmaceuticals Ltd. It lists 12 tests including description, identification, average weight, uniformity of weight, thickness, loss on drying, hardness, disintegration time, dissolution rate and assay. The tablet must contain 500 mg of cefuroxime axetil and meet limits for each test in order to be released. The shelf life is 36 months when stored below 25°C in a dry, light-protected place.

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994 views3 pages

FP Spec.

The document specifies the finished product requirements for Roximax 500 Tablet, an antibiotic manufactured by Veritas Pharmaceuticals Ltd. It lists 12 tests including description, identification, average weight, uniformity of weight, thickness, loss on drying, hardness, disintegration time, dissolution rate and assay. The tablet must contain 500 mg of cefuroxime axetil and meet limits for each test in order to be released. The shelf life is 36 months when stored below 25°C in a dry, light-protected place.

Uploaded by

ShagorShagor
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
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Download as DOC, PDF, TXT or read online on Scribd
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Product Development Department

Veritas Pharmaceuticals Ltd.


Gazipur, Bangladesh

SPECIFICATION OF FINISHED PRODUCT

Label Claim: Each film coated tablet contains


Product Name : Roximax 500 Tablet Cefuroxime 500 mg as Cefuroxime
Axetil USP
Document No. : SPEC/AB 011/FP/01 Version No.: : 01
Superseded Doc. : Nil Effective Date : 03/02/ 2014
Shelf Life : 36 months Review Date : 02/02/2017
Analytical Method
: TP/AB 011/00 Action & Use : Antibiotic
Ref. No.
Store in a dry & cool place (below 25C),
Storage Condition : Presentation : Blister (Alu-Alu, 2X8s)
Protected from light.

Sl No. TEST SPECIFICATION

A white to off-white colored capsule shaped film coated tablet having a break
01. Description
line on one side and other side embossed with VERITAS
02. Identification Must be positive for Cefuroxime Axetil
03. Average weight/Tablet (mg) 785.7 mg 834.3 mg (810.0 mg 3 %)
Out of 20 Tablets, maximum 2 Tablets shall deviate 5 of average weight and
04. Uniformity of weight
none shall deviate 10 % of average weight
05. Thickness 5.2 mm 5.8 mm
06. LOD (%)/Water (%) Not more than 6%
07. Average Hardness (Kp) Not less than 6.0 16.0

08. Disintegration time Not more than 30 minutes

Not less than 50% within 15 minutes


09. Dissolution
Not less than 70% within 45 minutes
USP 450.0 550.0 mg (90.0 110.0 % of the label claim)
10. Assay: Cefuroxime (mg/tablet)
In- House 475.0 525.0 mg (95.0 105.0 % of the label claim)
Batch No. : MRP:
11. Packaging Information
Mfg. Date: Exp. Date:
12. Check list Should meet
Product Development Department
Veritas Pharmaceuticals Ltd.
Gazipur, Bangladesh
Prepared by Checked by Approved by

Sign & Date

Designation Sr. Executive, PD Asst. Manager, QC QA Manager


Product Development Department
Veritas Pharmaceuticals Ltd.
Gazipur, Bangladesh
Reason for Revision Version: 01, To set Specification of Quinocin 500 Tablet

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