Ashland Specialty Ingredients www.ashland.

com

8145 Blazer Drive, Wilmington, DE 19808

Tel: (302) 594-5000

Product Specification
Report Id : WH0295 Page 1 of 2
Product: Issue Date: 9/1/2011
PVP K-30 PI * Revision Date: 7/8/2020
Effective Date: 7/8/2020

Chemical Description:
Department Approved By Date
Polymer of 1-vinyl-2-pyrrolidone.
Plant QA Mark Wrinkle 10/1/2019
Pharmaceutical grade K-30 PI.
Mod+Base Code : 101_72531
Material Codes : 831159, 846160, 941315
Responsible Manufacturing Plants : Calvert City, Texas City

Charcoal treated USP GMP Grade

SPECIFICATIONS PLANT RELEASE LIMITS SALES SPECIFICATIONS

Appearance @ 25 deg C - White to White to creamy white powder
creamy white powder
* Identification Tests (Q232 & W1125) - Meets all ID tests
Meets all ID tests
% Moisture (Karl Fischer, W1525) >=0 - <=4.0 <=5.0
pH (5% as is aqueous solution, W622) >=3.0 - <=5.0 >=3.0 - <=5.0
* % Ash (Residue on Ignition or >=0 - <=0.1 <=0.1
Sulphated, W1381)
ppm Vinyl Pyrrolidone (HPLC, W1245) >=0 - <=9.0 <=10.0
%2-Pyrrolidone (W1406) >=0 - <=2.5 <=3.0
* ppm Heavy Metals (as lead, W1494) >=0 - <=10 <=10
% Aldehydes (Calculated as >=0 - <=0.05 <=0.05
acetaldehyde, W1411)
% Nitrogen (Solids Basis, W1118) >=11.6 - <=12.7 >=11.5 - <=12.8
K-Value (1% Solids w/v aqueous solution, >=27 - <=32 >=27 - <=32
W1307)
ppm Peroxide Content (Titanyl Sulfate >=0 - <=400 <=400
Method, W1378)
* ppm Hydrazine (W403) - Pass equals <=1.0
<=1.0

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Sales and Plant Specifications for all SKUs
 Ashland Specialty Ingredients www.ashland.com

8145 Blazer Drive, Wilmington, DE 19808

Tel: (302) 594-5000

Product Specification
Report Id : WH0295 Page 2 of 2
SPECIFICATIONS PLANT RELEASE LIMITS SALES SPECIFICATIONS
ppm Carbon Particles (W692) >=0 - <=1
ppm Insoluble Gel (APHA Sed Test, Pass Pass
W630)
ppm Insoluble Matter (APHA Sediment >=0 - <=10
Tester, W630)
Magnetic particle >=0 - <=0
* Total Aerobic Plate Count, CFU/g <=100
(Q200) - Pass equals <=100

* Mold/Yeast, CFU/g (Q200) - Pass <=100

equals <=100
* Staphylococcus aureus CFU/g (Q200) - Negative
Pass equals Negative

* Salmonella, CFU/g (Q200) - Pass equals Negative

Negative
* Pseudomonas aeruginosa, CFU/g Negative
(Q200) - Pass equals Negative

* E. coli, CFU/g (Q200) - Pass equals Negative

Negative
% Formic Acid (W583) >=0 - <=0.5 <=0.5

Meets requirements for Povidone in current USP/NF. * Results for ID testing,

Ash, Heavy Metals, Hydrazine and Microbial tests are based on quarterly testing..

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Sales and Plant Specifications for all SKUs