LEON PHARMACEUTICALS LIMITED

Satkhamair, Sreepur, Gazipur.

Department Quality Assurance
Title In-Process Analysis Request & Report Sheet
Granules for Suspension MO No.:

From: Production Department To: QA Department

Product Name : Novaflox GFS 60 ml Batch No.:
Product Code : NFGS01 Batch Size:
Product Strength: Ciprofloxacin 250 mg/ 5 ml QC Ref No.:

Sl. Production Department Quality Control Department

No.
01. ANALYSIS REQUEST SPECIFICATIONS ANALYSIS REPORT
Interim report after Filling:
1. Appearance 1. A mixture of white and pink coloured spherical pellets. 1.
2. Identification 2. Must comply with the identification test of 2.
Ciprofloxacin.
3. Loss on drying 3. Not more than 3.5 %w/w. 3.
4. Assay 4. Between 19.50% and 20.50 %of Ciprofloxacin. 4.
5. Advised weight per phial 5. Between 14.99 gm and 15.76 gm. 5.
Remarks:
Signature & Date:____________ Signature ( QC) & Date:_____________
02. Interim report after Reconstitution:
1. A pink colour homogeneous viscous suspension having
1. Appearance 1.
strawberry flavour.
2. A flavour of strawberry.
2. Odour 2.
3. Palatable.
3. Taste 3.
4. 8.0 to 11.0.
4. pH 4.
5. 60.0 ml to 61.0 ml.
5. Volume 5.
6. 1.10 g/ml to 1.30 g/ml.
6. Weight per ml 6.
Remarks:
Signature &Date:_____________ Signature ( QA) & Date:_____________
03. Interim report after Sealing:
1. Leak Test 1. Must be Leak Proof. 1.

Remarks:
Signature &Date:_____________ Signature ( QA) & Date:_____________
Final report after Packing:
04. 1. Batch No. 1. . 1.
2. Mfg. Date & Exp. Date 2. Mfg. Date: .. & Exp. Date: 2.
3. Price ... 3.
3.
Signature &Date:_____________ Remarks:
Signature (QA) & Date:_____________

Checked by : Date :

Form No : QA/ FORM /IPC/NFGS01 Version :01 Effective Date : 01.06.2014