Povidone and Crospovidone9003-39-8

Povidone-iodine betadine is yellow-brown to red-brown amorphous powder, soluble in water or ethanol, insoluble in ether or chloroform. Side effects include skin irritation. If applied to large wounds, poor renal function may cause hypernatremia and metabolic acidosis. It is not recommended for people who are pregnant for less than 32 weeks or who take lithium salts. People with thyroid problems are advised not to use it frequently. Povidone iodine is a chemical polymer of povidone and element iodine. It contains 9% to 12% iodine. Its mechanism of action is the death of microorganisms caused by the release of iodine. Povidone-iodine is an over-the-counter medicine.

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Product Introduction

Traits:

Povidone and Crospovidone9003-39-8** (CAS 9003-39-8) are complementary polyvinylpyrrolidone polymers. Povidone (K30) acts as binder/solubilizer; crosslinked Crospovidone functions as superdisintegrant. Pharmacopeial grades (USP/Ph.Eur) for solid dosage optimization.

Povidone-iodine betadine is yellow-brown to red-brown amorphous powder, soluble in water or ethanol, insoluble in ether or chloroform.

Side effects include skin irritation. If applied to large wounds, poor renal function may cause hypernatremia and metabolic acidosis. It is not recommended for people who are pregnant for less than 32 weeks or who take lithium salts. People with thyroid problems are advised not to use it frequently. Povidone iodine is a chemical polymer of povidone and element iodine. It contains 9% to 12% iodine. Its mechanism of action is the death of microorganisms caused by the release of iodine. Povidone-iodine is an over-the-counter medicine.

Pharmacopoeia standards:

1.Main active ingredients

Complex of 1-vinyl-2-pyrrolidone homopolymer and iodine. Calculated as dry product, the content of available iodine (I) should be 9.0% to 12.0%.

2.Traits:

Yellow-brown to red-brown amorphous powder. It is soluble in water or ethanol, but insoluble in ether or chloroform.

3.Identify：

Take about 0.5g of this product, add 5ml of water to dissolve, and test according to the following method.

(1) Take 1 drop of the solution, add 9ml of water and 1ml of starch indicator solution, it will appear dark blue.

(2) Take 0.5ml of the solution, spread it on a glass plate with an area of about 7.5cm×2.6cm, and place it overnight at low humidity and room temperature to dry, forming a brown, dry film that is easily soluble in water.

Synergistic Applications

Povidone and Crospovidone9003-39-8** enable:

►Instant-release tablets: Povidone binds + Crospovidone disintegrates (<30 sec)

►Bioavailability enhancement: Povidone solubilizes BCS II/IV APIs; Crospovidone accelerates dissolution

►Melt extrusion: Povidone forms solid dispersions; Crospovidone prevents gelling

►Direct compression: Dual-action system reduces excipient count

►Stabilization: Povidone inhibits crystallization; Crospovidone absorbs moisture

Application：

Povidone-iodine	CP2005/USP26	USP31	EP6.0
Appearance	Brown-red or yellow-brown amorphous powder
available iodine %	9.0-12.0	9.0-12.0	9.0-12.0
max iodine ions %	6.6	6.6	6.0
heavy metal ppm max	20	10	--
sulfate ash %max,	0.1	0.025	0.1
nitrogen content	9.5-11.5	9.5-11.5	一
pH value (10% aqueous solution),	--		1.5-5.0
weight loss on drying %max	8.0	8.0	8.0

productioSpecifications

Products name	Povidone K30	Products name	Crospovidone
CAS No	9003-39-8	CAS No	9003-39-8
K-value	27.0–32.4	Swelling Capacity	550–650% (0.1N HCl)
Residual NVP	≤100 ppm (GC)	Particle Size	90% <100μm
Viscosity	3.5–7.5 mPa·s (5% sol)	Water Uptake	≥5.0 ml/g