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Povidone (PVP K-series) Technical Data Sheet - Pharma Grade

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Chemical Name: Polyvinylpyrrolidone (PVP)
Name: Povidone(PVP)
CAS NO. : 9003-39-8
Molecular formula: (C6H9NO)n
Availability:

Product Description:

The polyvinylpyrrolidone (Povidone) series, including K15, K17, K25, K30 and K90, are high-quality pharmaceutical excipients that meet EP and USP standards.
They have excellent hygroscopicity, film-forming properties and complexing abilities, making them very suitable for cosmetic, pharmaceutical and industrial applications.
These products are certified to ensure compliance with international quality and safety standards, providing market access and buyer confidence.


  • Structure formula:

Povidone (PVP K-series)

  • Appearance: White or yellowish-white powder

  • CDE register number: K30: F20209990878,K90: F20230000040

  • Application: K25, K30: binders, film formers, dispersers, stabilisers for oral preparation:

    K90: binders,thickeners, stabilisers for oral preparation.



Product specifications:



PVP K15

PVP K17

PVP K25

PVP K30

PVP K60

PVP K90

PVP K120

pH

3.0-5.0

3.0-5.0

3.0-5.0

3.0-5.0

4.0-7.0

4.0-7.0

4.0-7.0

K-value

12.75-17.25

15.30-18.36

24.0-27.0

27.0-32.4

54.0-64.8

81.0-97.2

108.0-130.0

Aldehydes (ppm)

≤500

≤500

≤500

≤500

≤500

≤500

≤500

Peroxides (ppm)

≤400

≤400

≤400

≤400

≤400

≤400

≤400

Formic acid (%)

≤0.5

≤0.5

≤0.5

≤0.5

≤0.5

≤0.5

≤0.5

Hydrazine (ppm)

≤1

≤1

≤1

≤1

≤1

≤1

≤1

NVP (ppm)

≤10

≤10

≤10

≤10

≤10

≤10

≤10

2-Pyrrolidone(%)

≤3.0

≤3.0

≤3.0

≤3.0

≤3.0

≤3.0

≤3.0

Heavy Metals (ppm)

≤10

≤10

≤10

≤10

≤10

≤10

≤10

Water (%)

≤5.0

≤5.0

≤5.0

≤5.0

≤5.0

≤5.0

≤5.0

Sulfated ash (%)

≤0.1

≤0.1

≤0.1

≤0.1

≤0.1

≤0.1

≤0.1

Nitrogen (%)

11.5-12.8

11.5-12.8

11.5-12.8

11.5-12.8

11.5-12.8

11.5-12.8

11.5-12.8


All products comply with Ph. Eur, USP/NF, JP,BP certificate of analysis.

  • PVP K15: This grade has a pH value ranging from 3.0 to 5.0, a K value between 12.75 and 17.25, and a water content of less than or equal to 5.0%. The solid content is not specified, the level of peroxides is below 400 ppm, and the hydrazine content is at or below 1 ppm.
  • PVP K17: Features a pH range of 3.0 to 5.0, a K value from 15.30 to 18.36, and a water content of less than or equal to 5.0%. The peroxides level is kept below 400 ppm, and the hydrazine content is at or below 1 ppm.
  • PVP K25: This variant has a pH value from 3.0 to 5.0, a K value between 24.0 and 27.0, and a water content of less than or equal to 5.0%. The peroxides are below 400 ppm, and the hydrazine content is at or below 1 ppm.
  • PVP K30: It has a pH value from 3.0 to 5.0, a K value ranging from 27.0 to 32.4, and a water content of less than or equal to 5.0%. The peroxides are below 400 ppm, and the hydrazine content is at or below 1 ppm.
  • PVP K60: With a pH range of 4.0 to 7.0, a K value from 54.0 to 64.8, and a water content of less than or equal to 5.0%. The peroxides are below 400 ppm, and the hydrazine content is at or below 1 ppm.
  • PVP K90: This grade features a pH value from 4.0 to 7.0, a K value between 81.0 and 97.2, and a water content of less than or equal to 5.0%. The peroxides are below 400 ppm, and the hydrazine content is at or below 1 ppm.
  • PVP K120: It has a pH range of 4.0 to 7.0, a K value from 108.0 to 130.0, and a water content of less than or equal to 5.0%. The peroxides are below 400 ppm, and the hydrazine content is at or below 1 ppm.



Packaging and Storage:


Packed in 25 kg plastic drum or fiber drum, inner lined with PE bags. Special packing is available according to customer's requirement. Preserve in tight containers.



FAQ:


Q1: What are the primary applications of Povidone (PVP K-series) in pharmaceuticals?


A1: Povidone (PVP K-series) is primarily used as a binder, film-former, and disintegrant in oral preparations. It is suitable for a variety of pharmaceutical applications, including tablets, capsules, and granules, ensuring improved dissolution rates and bioavailability of drugs.


Q2: What are the key specifications of Povidone (PVP K15)?


A2: Povidone (PVP K15) has a pH range of 3.0 to 5.0, a K value between 12.75 and 17.25, and a water content of less than or equal to 5.0%. It contains less than 500 ppm of aldehydes and peroxides, and less than 1 ppm of hydrazine.


Q3: How does Povidone (PVP K-series) meet regulatory standards?


A3: All Povidone (PVP K-series) products comply with Ph. Eur, USP/NF, JP, and BP certificate of analysis, ensuring they meet international quality and safety standards.


Q4: What is the packaging and storage recommendation for Povidone (PVP K-series)?


A4: Povidone (PVP K-series) is packed in 25 kg plastic drums or fiber drums, inner lined with PE bags. It should be stored in tight containers to maintain its quality and stability.


Q5: What are the benefits of using Povidone (PVP K-series) in pharmaceutical formulations?


A5: Povidone (PVP K-series) offers benefits such as improved dissolution rates, enhanced bioavailability, and increased stability of pharmaceutical formulations.




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