LEON PHARMACEUTICALS LIMITED

Satkhamair, Sreepur, Gazipur.

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

From: Production Department To: QA Department

Product Name : Ketosma Syrup Batch No.:
Product Code : KMSY04 Batch Size:
Product Strength : Ketotifen 01.00 mg / 5ml QC Ref No.:

Sl. Quality Control Department

No. Production Department

01. ANALYSIS REQUEST SPECIFICATIONS ANALYSIS REPORT

Interim report after mixing thoroughly:
1. Appearance 1. A mango flavoured liquid having sweet taste free from 1.
any visible foreign particles.

2. Identification 2. Must comply with the identification test for Kitotifen 2.

Fumarate .
3. Odour 3.
3. A blended flavour of mango .
4. Taste 4.
4. Palatable .
5. pH 5.
5. 3.5 to 5.0 .
6.
6. 1.18 g/ml to 1.30 g /ml.
6. Weight per ml
7.
7. 95% to 105% of the stated amount of Kitotifen .
7. Assay: (Active Ingredient/5ml)

Remarks:
Signature & Date:____________ Signature (QC) & Date:_____________

02. Interim report at the beginning of Filling:

1. Filled Volume 1. 100.00 ml to 101.50 ml.

1.

2. Cap Leakage Test 2. Must be leak proof.

2.
Remarks:
Signature &Date:_____________ Signature (QA) & Date:_____________

03. Final report after Packing:

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/ KMSY04 Version: 01 Effective Date: 01.06.2014