LEON PHARMACEUTICALS LIMITED

Satkhamair, Sreepur, Gazipur.

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

From: Production Department To: QA Department

Product Name : Novazith PFS 35 ml Batch No.:

Product Code : NZPS04 Batch Size:
Product Strength: Azithromycin Dihydrate (209.6 + Overage 2.5 %) mg / 5 ml QC Ref No.:

Sl. Production Department Quality Control Department

No.
01. ANALYSIS REQUEST SPECIFICATIONS ANALYSIS REPORT
Interim report after Blending: 1. An off- white powder.
1. Appearance 2. Must comply with the identification test of 1.
2. Identification Azithromycin. 2.
3. Loss on drying 3. Not more than 1.5 %w/w. 3.
4. Blend uniformity 4. Complies with BP 2007 limit. 4.
5. Assay 5. 7.30 % 2.5 % (7.12 % and 7.48 %) of Azithromycin 5.
Dihydrate.
6. Advised weight per phial 6. 20.59 mg 2.5 % ( 20.075 gm and 21.105 gm). 6.
Remarks:
Signature & Date:____________ Signature (QC) & Date:________________________

02. Interim report after Reconstitution:

1. An off-white viscous suspension.
1. Appearance 1.
2. A flavour of mango.
2. Odour 2.
3. Palatable.
3. Taste 3.
4. 7.5 to 9.5.
4. pH 4.
5. 14.7 ml to 15.3 ml.
5. Volume 5.
6. 1.15 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:________________________

04. Final report after Packing:

1. Batch No. 1. . 1.
2. Mfg. Date & Exp. Date 2. Mfg. Date: .. & Exp. Date: ... 2.
3. Price 3. 3.

Checked By: ____________________ Date: ______________________

Form No.: QA/FORM/IPC/NZPS04 Version: 01 Effective Date: 01.06.2014