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Superseded Doc.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