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povidone,KoVidoneTMK-PVP K Series

  • Brands: 药品/原材料
  • Model:
  • Description: USP and EP Name:Povidone(Povidonum)
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Properties:
White or creamy white powder,odourless,nontoxic,non-irritant,dissolves readily in water,alcohol,amine and many other organic solvents.PVP K Series is widely used in pharmaceutical fields,thanks to it’s excellent solubility,film-formingcapability, chemical stability,physiologicalinertia and cementability.

Quality Standard:CP2005.Ph.EP.,USP/NF.BP.


KoVidone TM
K12
K15
K17
K25
K30
K60
K90
Appearance
White or off-white powder
K value
10.2-13.8
12.75-17.25
15.3-18.36
22.5-27.0
27-32.4
54-64.8
81-97.2
N-Vinylpyrrolidone
(Impurity A)
(CP2005/USP26) %max
0.1
0.1
0.1
0.1
0.1
0.1
0.1
(USP31/EP6/BP2007) ppm max
10
10
10
10
10
10
10
Moisture                        % max
5.0
5.0
5.0
5.0
5.0
5.0
5.0
Solid content                   % min
95
95
95
95
95
95
95
pH value(5%in aqueous solution)
3.0-5.0
3.0-5.0
3.0-5.0
3.0-5.0
3.0-5.0
4.0-7.0
4.0-7.0
Sulphate Ash                    % max  
0.1
0.1
0.1
0.1
0.1
0.1
0.1
Nitrogen content                  %
11.5-12.80
11.5-12.80
11.5-12.80
11.5-12.80
11.5-12.80
11.5-12.80
11.5-12.80
2-Pyrrolidone (Impurity B)       % max        
3.0
3.0
3.0
3.0
3.0
3.0
3.0
Aldehyde(as acetaldehyde)        ppm max
500
500
500
500
500
500
500
Heavy metal (as Pb)              ppm max
10
10
10
10
10
10
10
Hydrazine                        ppm max
1
1
1
1
1
1
1
Peroxide(As H2O2)                 ppm max
400
400
400
400
400
400
400

Application:
KoVidoneTMK products possess excellent adhesive,film-forming,dispersing and thickening properties,which are widely used in the pharmaceutical industry.They are one of the three main  accessory  products recognized & approved worldwide.

General Summarization:*Low molecular weight KoVidoneTMK ,for use as a solubilizing agent,crystallization inhibitor and suspension stabilizer in injectables and ophthalmic formulations.Such as KoVidoneTMK12,K15,K17.*Medium Molecular KoVidoneTMK,for use as binder in tablets,capsules and granulers,as a stabilizer for oral suspensions,film-forming agent,soluilizing agent,dispersant for pigments,as an enzyme stabilizer and to imrove bioavailability.e.g.KoVidoneTMK25,K30.*High molecular KoVidoneTMK ,a highly effetive binder,for us as stabilizer in oral and topical suspensions,as a thickener,hydropilizing agent e.g.KoVidoneTMK60,K90.

  1. Binder of Tablets:KoVidoneTMK25,K30,K90 all possess high binding strengths,they are suitable for the wet granulation and direct compression of tablets. KoVidoneTMK25 is used more than K30 and K90,due to its low viscosity.Conversely, KoVidoneTMK90 is used less due to its high binding properties.
  2. Solubilizers,Solventsand Crystallization inhibitors:Low molecular weight KoVidoneTMK12,K15,K17 are intended for use as solubilizing agents,dispersants and crystallization inhibitors,suspension stabilizers for injections and ophthalmic products.
  3. Dispersant or coprecipitator agent: KoVidoneTMK25 or K30 act as a comilling or coprecipitation agent in drugs which do not dissolve readily,and will greatly improve the dissolutionb rate of the drug.The method used is to mix the KoVidoneTM and drug,and then spray this onto a carrier,granulation or tablet.
  4. Suspension stabilizer: KoVidoneTMK25,K30 andK90 are suitable for the stabilizing of suspensions with a wide range of active ingredients;the results will be improved if KoVidoneTMK90 is used with PolyKoVidoneTM.
  5. Film/sugar Coatings,film formers: KoVidoneTM K25,K30 act a film-forming agents,adhesion promoters and pigment dispersers,and are often used as sugar coating and film coating.
  6. Thickening agents: KoVidoneTMK90 is suitable for use as a thickening agent for aqueous-alcoholic solutions for oral and topical suspensions.
  7. Pore-former:KoVidoneTMK30 can be applied as pore-former in taste-masking formulations and K90 can be as pore forming agent in medical plastcis.
  8. Improvement bioavailability,controlled release aid: KoVidoneTMK12,k15,17,K30,K90 can be used to adjust the dissolving speed of some hardly soluble actives.
  9. Food Fields:KoVidoneTMK25,K30,K60,K90 can be used in dietetic tablets,e.g.Vitamin,dietary fibre tablets,sweeteners.
  10. Other Applications: capsule flow aid ,cleaning fluids for contact lenses,enzyme and sensitive medicines stabilization,cryoprotector.

Remarks: KoVidoneTM is available for Cosmetic/Personal care applications,they are requested subject to special quality and purity controls of the cosmetic/personal care formulations needed.

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