Navana Pharmaceuticals Ltd.

Rupshi, Narayanganj, Bangladesh

Product Name:Flubiotic 250 Capsule Generic Name:Flucloxacillin Capsule BP, 250 mg
QUALITY ASSURANCE DEPARTMENT
PRE QUALIFICATION DOCUMENT
CERTIFICATE OF ANALYSIS (COA) OF ACTIVE AND EXCIPIENTS

1.0Certificate of Analysis (COA) of Flucloxacillin Sodium BP (Compacted)

Material Name Flucloxacillin Sodium BP (compacted)

Code RA-F08C Batch No. 8C03121
Manufacturing Date 03/2018 Expiry Date 02/2020
Date of Analysis 09/05/18 QC Reference No. 0033RMPN18
Manufacturer Name Square Pharmaceuticals Ltd, Dhaka

Sl. Parameters Specifications Result

No.
1. Appearance White or almost white, hygroscopic, crystalline white, hygroscopic,
powder. crystalline powder
2. Identification
A. IR IR spectrum of the sample should concordant Positive
with that of reference standard
B. TLC The principal spot in the chromatogram obtained Complies
with the test solution is similar in position, color
and size to the principal spot in the
chromatogram obtained with the reference
solution (a)
C. Color development The solution become yellow Complies
D. Reaction of Sodium It gives the reaction of Sodium Complies
3. Solubility Freely soluble in water and in methanol, soluble Complies
in ethanol (96%)
4. Appearance of Solution Solution S is clear and its absorbance at 430 nm Clear
(10% w/v) in water is not greater than 0.04 0.007
5. pH (10% w/v in water) 5.00-7.00 5.37
6. Specific Optical Rotation +158° to +168°(anhydrous substance) +158.68°(OAB)
7. Water Content (3.00-4.50)% 3.90%
8. Related Substances
Impurities A,B,C,D,E Not more than 1.0% (For each impurity) 0.73%
Total Impurity Not more than 5.0% 1.34%
9. N.N-Dimethylaniline Not more than 20 ppm Nil
10. 2-Ethylhexanoic acid Maximum 0.8% <0.8%
11. Assay 95.0% to 102.0% (anhydrous substance) 100.18%(OAB)
Additional Test
12. Tapped Density 0.75 to 0.85g/ml 0.84 g/ml
Remarks: The material complies as per above specification.

Prepared by Checked by Reviewed By Approved by

Selina Afroze Md. Tubarak Hossain Md.MashudRana Deb Narayan Biswas
Executive, QA Asst. Manager, QA Manager, QA DGM, QA
 Navana Pharmaceuticals Ltd.
Rupshi, Narayanganj, Bangladesh
Product Name:Flubiotic 250 Capsule Generic Name:Flucloxacillin Capsule BP, 250 mg
QUALITY ASSURANCE DEPARTMENT
PRE QUALIFICATION DOCUMENT
CERTIFICATE OF ANALYSIS (COA) OF ACTIVE AND EXCIPIENTS

2.0Certificate of Analysis (COA) of Lactose Monohydrate (Granulac- 200)

Material Name Lactose Monohydrate BP (Granulac 200)

Code RE-L01 Batch No. 0001494232
Manufacturing Date 03-05-2017 Expiry Date 02-05-2022
25-03-2018 to
Date of Analysis QC Reference No. 0073RM18
31-03-2018
Manufacturer Name Mingtai Chemical Co., Ltd. Thiwan

Sl. Parameters Specifications Results

No.
1. Appearance White or almost white crystalline powder. Complies
2. Identification
IR Spectrum of the test sample is concordant with that of
A. IR Complies
reference Standard.
The principal spot in the chromatogram obtained with the
test solution is similar in position, colour and size to the
B. TLC Complies
principal spot in the chromatogram obtained with reference
solution (a).
Color
C. Must comply as per BP Complies
development
D. Water content 4.5 – 5.5% 5.19%
3. Freely but slowly soluble in water, practically insoluble in
Solubility Complies
ethanol (96 %).
4. Appearance of solution
The solution is clear and not more intensely coloured than
(10% w/v solution in Complies
reference solution BY7.
water)
5. Acidity or alkalinity Must comply as per BP Complies
6. Specific optical rotation+ 54.40 to + 55.90 (anhydrous substance) +55.16°(OAB)
7. Absorbance At 400 nm : Maximum 0.04 for test solution (a)
From 210 nm to 220 nm : Maximum 0.25 for test solution 0.014
(b) 0.097 ̴ 0.063
From 270 nm to 300 nm : Maximum 0.07 for test solution 0.016 ̴ 0.004
(b)
8. Heavy metals Not more than 5 ppm. <5.0ppm
9. Sulphated ash Not more than 0.10% 0.07%
10. Microbial contamination TAMC: Not more than 102 CFU/gram. 40 CFU/gram
Escherichia coli: Nil Absent
11. Sieve test Minimum 80% passes through 200 mesh 92.69% Passes
Remarks: The material complies as per above specification.

Prepared by Checked by Reviewed By Approved by

Selina Afroze Md. Tubarak Hossain Md.MashudRana Deb Narayan Biswas
Executive, QA Asst. Manager, QA Manager, QA DGM, QA
 Navana Pharmaceuticals Ltd.
Rupshi, Narayanganj, Bangladesh
Product Name:Flubiotic 250 Capsule Generic Name:Flucloxacillin Capsule BP, 250 mg
QUALITY ASSURANCE DEPARTMENT
PRE QUALIFICATION DOCUMENT
CERTIFICATE OF ANALYSIS (COA) OF ACTIVE AND EXCIPIENTS

3.0Certificate of Analysis (COA) ofMagnesium Stearate BP

Material Name Magnesium Stearate BP

Code RE-M01 Batch No. C726244
Mfg. Date January-2017 Exp. Date January-2021
Date of Analysis 30.04.17 QC Reference No. 0328RM17
Manufacturer Name Samyang Corporation, Korea/Inkochem Corporation, Korea

Sl.
Parameters Specifications Result
No.
White or almost white, very fine, light powder, Almost white fine
1. Description
greasy to the touch. powder
2. Identification Must comply as per BP Complies
Practically insoluble in water and in anhydrous
3. Solubility Complies
ethanol.
4. Acidity or Alkalinity Must comply as per BP Complies
5. Chlorides Not more than 0.1% <0.1%

6. Sulphates Not more than 1.0% <1.0%

Not more than 6.0 per cent, determined on 1.000

7. Loss On Drying 4.16%
g by drying in an oven at 105 °C.
8. Cadmium Not more than 3 ppm < 3 ppm
9. Lead Not more than 10 ppm < 10 ppm
10. Nickel Not more than 5 ppm < 5 ppm

11. Stearic Acid &Palmitic Acid Must comply as per BP Complies

TAMC: Not more than 103cfu /g < 10 cfu/g
TYMC: Not more than 102cfu /g < 10 cfu/g
12. Microbial Contamination
Escherichia coli: Nil Nil
Salmonella: Nil Nil
It contains not less than 4.0 % and not more than
4.36% (as it is)
13. Assay 5.0 % of Mg calculated with reference to the
4.55% (ODB)
dried substance.

Remarks: The material complies as per above specification.

Prepared by Checked by Reviewed By Approved by

Selina Afroze Md. Tubarak Hossain Md.MashudRana Deb Narayan Biswas
Executive, QA Asst. Manager, QA Manager, QA DGM, QA
 Navana Pharmaceuticals Ltd.
Rupshi, Narayanganj, Bangladesh
Product Name:Flubiotic 250 Capsule Generic Name:Flucloxacillin Capsule BP, 250 mg
QUALITY ASSURANCE DEPARTMENT
PRE QUALIFICATION DOCUMENT
CERTIFICATE OF ANALYSIS (COA) OF ACTIVE AND EXCIPIENTS

4.0Certificate of Analysis (COA) ofEHGC Shell # 2(Common)

Material Name EHGC Shell # 2 (Common)

Code RE-CS2-08 Batch No. 1150024062
Mfg. Date 31.10.2017 Exp. Date 30.09.2022
Date of Analysis 23.12.2017 QC Reference No. 0859RM17
Manufacturer Name ACG Associated Capsules pvt. Ltd. India

Sl.
Parameters Specifications Result
No.
Unprinted empty hard gelatin capsule
1. Description shell of black opaque cap & red opaque Complies
body
2. Shell Size “2” “2”
3. L.O.D. 11.0 to 17.0% 14.25%
4. Outer Diameter of Cap 6.34-6.40 mm 6.40 mm
5. Outer Diameter of Body 6.05-6.11 mm 6.10 mm
6. Length of Cap 8.60-9.40 mm 8.80 ̴ 9.00 mm
7. Length of Body 14.80-15.60 mm 14.90 ̴ 15.10 mm
Length of Locked capsule shell
8. 17.40-18.20 mm 17.42 ̴ 17.68 mm
Average weight
9. 56 to 70mg/Cap 62.95 mg
Disintegration Time
10. Not more than 15 Minutes 6 minute 40 seconds
Microbial Limit Test:
i. Total Aerobic Microbial Count i. Not more than 500 cfu per gram 80 cfu/g
ii. Total Yeast &Mould Count ii. Not more than 100 cfu per gram 20 cfu/g
11. iii. Escherichia Coli iii. Must be absent Absent
iv. Salmonella iv. Must be absent Absent
v. Pseudomonas aeruginosa v.Must be absent Absent
vi.Staphylococcus vi. Must be absent Absent
Remarks: The material complies as per above specification.

Prepared by Checked by Reviewed By Approved by

Selina Afroze Md. Tubarak Hossain Md.MashudRana Deb Narayan Biswas
Executive, QA Asst. Manager, QA Manager, QA DGM, QA