PREVERT® 75 mg Coated Tablets P.5.

4 Batch Analyses

Product: Lodal® 40 mg Active Ingredient: Rosuvastatin

Pharmaceutical
Coated Tablet Bibliography: USP
Form:
Batch: F18064 Report Number: I-1624 180730
Manufacturing
06/2018 Login Date: 07/10/2018
Date:
Expiration Date: 06/2020 Analysis Date: 07/30/2018
Pharma Date of Issuance of
Manufacturer: 07/30/2018
Développement Report:
Test Specification Results
Blister of aluminum-aluminum
printed of 20 microns. The
Blister of aluminum-aluminum printed of 20
blister contains pink oval
microns. The blister contains pink oval coated
coated tablets with white or
1. Description tablets with white or almost white core and logo
almost white core and logo on
on one side. With 20 on the other side, free of
one side. With 20 on the other
strange visible particles
side, free of strange visible
particles
Average: 103.6%
Maximum: 103.9%
2. Uniformity of
Dosing Units
Meets the requirements(1) Minimum: 103.4%
Acceptance Value (AV): 2.5
Sample Size (N): 10
3. Friability ≤ 1% 0.4%
The peak retention time Rf values for the
4. Rosuvastatin main spots in the sample solution,
Positive
Identification corresponds to the main spots obtained from
the standard of Rosuvastatin.
5. Rosuvastatin 40 mg/ coated tablet. Average weight 39.5 mg / Coated Tablet
Assay (36.0 – 44.0 mg), [90.0 – 110.0%] 98.8%
No more than 1% of any individual impurity
6. Related Not detected
Compounds
is found. Not detected
Total impurities are no more than 1.5%.
Unity 1: 98.5%
No unit is less than Q + 5 %. Where Q = 75 Unity 2: 98.0%
%. 900 mL of Citrate Buffer pH 6.6 Unity 3: 97.8%
7. Rosuvastatin
Dissolution
Appliance: Number 2 (USP) Unity 4: 99.0%
Time: 45 minutes Unity 5: 98.8%
Speed: 50 RPM Unity 6: 98.4%
Average: 98.4%
(1) The acceptance value (AV) is not greater than L1% (15.0) for 10 analyzed units. If the acceptance

value is greater than L1%, analyze 20 more units and calculate the acceptance value. Content
uniformity requirements are met if AV is less than or equal to L1% for all 30 units and the individual
content of no unit is less than [1-(0.01)(L2)]M or greater than [1+(0.01)(L2)]M, where L2 is 25.0 and M is
the reference value according to USP.
This product has been manufactured in accordance with Global guidelines. The batch has been elaborated with the
requirements of Good Manufacturing Practices.
Resolution: Approved by Quality Control
Date of Resolution: 30- July- 2018
PREVERT® 75 mg Coated Tablets P.5.4 Batch Analyses