BIOLIFE MEDICAL PRIVATE LIMITED.
1-21, SITE:IV, UPSIDC IND. AREA, KASNA, GREATER NOIDA, 201206 (U.P.), INDIA.
FORMNO.+ BLFP-001 O18 [EFFECTIVE DATE :20-10-2076 REVIEW DATE 1 19-10-2018
FINISHED PRODUCT CERTIFICATE OF ANALYSIS:
(Issued under drug and cosmetic act 1940 and the rules there under)
Mig ic. No. 04/sc/P of 2015
Product Name : Blood Bag with Anticoagulant Citrate Phosphate Dextrose Adenine
(CPDA Solution ) as per IP
QC Report No.: BL-FP-QC-18024-S Reference : IP 2018
Batch No.: 210518024-S Batch Size: 2200 Bags(450m! Quadruple
with PDS)
05-2018 Exp. Dat 04-2020
25 Bags Date of Sampling: 23/05/2018
Description: PVC Bag Containing Clear, Colourless liquid; Odourless
Tdentification: Positive test for Citrate, Phosphate, Dextrose and Adenine
Extractable volume : 65 mi Claim: 63 mi 410%
pH 5.76 Limit: 5.0 to 6.0
ASSAY : EACH 100 ML CONTAINS.
NAME OF CONTENTS CLAIM RESULT. Limit
Total Citrate 2.017 9m —2.016gm 1.916 to 2.118 gm
Sodium Dihydrogen Phosphate 0.251gm _0.2499m 0.238 to 0.263 gm
(ihydrate)IP
Dextrose (Monohydrate) IP 3.19 gm —_3.189gm 3.030 to 3.350 gm
Total Sodium 0.654.9m 0.6489m 0.621 to 0.686 gm
Adenine (Anhydrous)1P 0.0275 gm 0.0283am 0.0261 to 0.0289 gm
JOther tests QC report No.
Steriity : Passes the test BL-ST-QC-18024-S
Bacterial Endotoxin Passes the test BL-BT-QC-18024-S
Empty Finished bag : Passes the test BL-E8-QC-18024-S
Particulate Contamination : Passes the test BL-PM-QC-18024-S
as ee
Result : The Sample Compliés/Does nof Comply with IP/tnhouse Specification.
Tou oolat\rd
[Signature Analyst Date