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CoA Povidone K30 S

This certificate of analysis from BASF S.A. provides testing results for a shipment of 45kg plastic drums of Povidone K30 S. The tests show the product meets specifications for appearance, smell, solubility, identification, pH, viscosity, contaminants, assay, and microbial limits. The certificate confirms the product is in agreement with specifications and meets the requirements of USP/NF and ChP monographs for povidone.

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Dheyne Telles
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0% found this document useful (0 votes)
521 views2 pages

CoA Povidone K30 S

This certificate of analysis from BASF S.A. provides testing results for a shipment of 45kg plastic drums of Povidone K30 S. The tests show the product meets specifications for appearance, smell, solubility, identification, pH, viscosity, contaminants, assay, and microbial limits. The certificate confirms the product is in agreement with specifications and meets the requirements of USP/NF and ChP monographs for povidone.

Uploaded by

Dheyne Telles
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
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Certificate of Analysis

BASF S.A.

Please note that the certificates of analysis are also conveniently available on your BASF online portal.

BASF S.A. 2023-02-27 Certificate No 7765


Page 1 of 2
AV DAS NACOES UNID 14171, 10º A 17º
jerome.xu@basf.com
04794-000 SAO PAULO
VILA GERTRUDES +86-21-38106158
Brasil
Certificate of Analysis according to DIN 55350-18-4.2.2

Material 50485997
Povidone K30 S
Order 7012275105 000010
Delivery 7616589967 000010
45KG Plastic drums
Lot 046-220057
Purchase order/Customer material
Lot/Qty 4005.000 KG
ON - # Z_enp-br00000292 - 550034482
Total 4005.000 KG
Transport 00000000001152144792

______________________________________________________________________________________________________________
Lower Upper
Characteristic Unit Value Limit Limit
______________________________________________________________________________________________________________
Appearance: White or milky white powder CONFORMS
Smell: Odorless or slight odor CONFORMS
*Solubility: Must comply CONFORMS
Identification(IR): Must comply CONFORMS
Identification (dichromate):Must comply CONFORMS
Identification (thiocyanate):Must comply CONFORMS
Identification (iodine):Must comply CONFORMS
*Clarity and color of Sol.: Must comply CONFORMS
pH value 3.7 3.0 5.0
Viscosity, expressed as K value 29.1 27.0 32.0
Aldehydes, expressed as Acetaldehyde mg/Kg 60 500
Peroxides, expressed as H2O2 mg/Kg 56 400
Hydrazine mg/Kg < 1 1
Vinylpyrrolidone(HPLC) mg/Kg < 1 10
2-Pyrrolidone g/100g 1.5 2.0
Heavy metals mg/Kg < 10 10
Lead mg/Kg < 10 10
Water g/100g 2.5 5.0
Residue on ignition g/100g < 0.1 0.1
Formic acid g/100g 0.3 0.5
Assay: Nitrogen, anhydrous basis g/100g 12.2 11.5 12.8
Total aerobic microbial count(TAMC) CFU/g < 10 200
Total combined yeasts and moulds(TYMC) CFU/g < 10 20
______________________________________________________________________________________________________________
* Solubility(not routinely tested): Freely soluble in water, methanol or ethanol, very slightly soluble
in acetone, practical insoluble in
ether.
* Clarity and color of solution: Clear and colorless, opalescence not more than reference solution 1,

The aforementioned data shall constitute the agreed contractual quality of the product at the time of passing of risk. The data are controlled at regular intervals as
part of our quality assurance program. Neither these data nor the properties of product specimens shall imply any legally binding guarantee of certain properties
or of fitness for a specific purpose. No liability of ours can be derived therefrom.

This is a computer-generated document. No signature is required.


Certificate of Analysis

BASF S.A.

Please note that the certificates of analysis are also conveniently available on your BASF online portal.

BASF S.A. 2023-02-27 Certificate No 7765


Page 2 of 2
AV DAS NACOES UNID 14171, 10º A 17º
jerome.xu@basf.com
04794-000 SAO PAULO
VILA GERTRUDES +86-21-38106158
Brasil
Certificate of Analysis according to DIN 55350-18-4.2.2

Material 50485997
Povidone K30 S
Order 7012275105 000010
Delivery 7616589967 000010
45KG Plastic drums
Lot 046-220057
Purchase order/Customer material
Lot/Qty 4005.000 KG
ON - # Z_enp-br00000292 - 550034482
Total 4005.000 KG
Transport 00000000001152144792

color not more intense than standard


solution Y1 or BR2.

Manufacturer: BASF Advanced Chemicals Co., Ltd.


Address: No.300 Jiang Xin Sha Road, Pudong New District, Shanghai 200137, P.R. China
Product is in agreement with specifications.

The product meets the requirements of the current “povidone” monograph of USP/NF and ChP.

The above information is derived from our Product Quality Testing. It is


provided in good faith and is subject
to BASF's terms and condition of sale. It does not relieve the purchaser
from the need to examine the product
upon delivery and gives no assurance as to the suitability of the
product for any particular use.

Released by Jerome XU
Production date 23.09.2022
Release date 28.10.2022
Retest date 22.09.2025

The aforementioned data shall constitute the agreed contractual quality of the product at the time of passing of risk. The data are controlled at regular intervals as
part of our quality assurance program. Neither these data nor the properties of product specimens shall imply any legally binding guarantee of certain properties
or of fitness for a specific purpose. No liability of ours can be derived therefrom.

This is a computer-generated document. No signature is required.

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