POVIDONE IODINE IP/ BP/ EP

TYPICAL CERTIFICATE OF ANALYSIS
TEST	SPECIFICATION	RESULT
Discription	Reddish Brown Colour Powder	Reddish Brown Colour Powder
Solubility	Soluble in water & alcohol it is practically insoluble in acetone	Complies
Identification (A & B)	A : A deep blue colour produced B : A dry brown colour film formed, which is readily dessolved in water	Complies Complies
Heavy Metals	Maximum 20 ppm	< 20 ppm
Nitrogen	9.5% to 11.5% w/w (on dried basis)	10.40% w/w (on dried basis)
Iodide	Maximum 6.6% w/w	3.78% w/w Complies
Sulphated Ash	Negligible	Complies
Loss on drying	Maximum 8.0% w/w	3.05% w/w
Assay	9.0% to 12.0% w/w (on dried basis)	11.35% w/w of available Iodine (on dried basis)

The product meets the specifications of the monographs IP/BP/EP

MATERIAL SAFETY DATA SHEET
POVIDONE IODINE IP/ BP/ EP

SECTION I

SECTION II - HAZARDOUS INGREDIENTS

Ingredients	CAS #	%w/w	Expos. Limit	Toxicity
Polyvinylpyrrolidone-Iodine Complex (NVPI	25655-41-8	60-100	Not established	LD50 Oral-rate 5600 mg/kg

SECTION III - PHYSICAL DATA

Boiling Point (°F)	N/A	VAP Pressure	< 0.1 mbar@ 20⁰C
Melting Point	N/A	Vapour Density (Air=1)	N/A
Decomp Temp	>350⁰ C (Geigy - Kuehner>	Volatiles (%wt)	N/A
Appearance and Odor	Brown free- flowing powder, characteristic odour

SECTION IV - HAZARDOUS REACTIVITY

Instability

Incompatibility

Decomposition

Polymerization

SECTION-V - FIRE AND EXPLOSION HAZARD DATA

Flash Point	> 100 C	Method	DIN 51758
Auto-Ignition Temp	N/D	Flammablelimits in air (% by volume	N/A
Lower	N/A	Upper	N/A
Extinguishig . Media [x] water [x] water FOG [ ] CO2 [] Foam [ ] Dry Chemical
Other	N/D	Burning Rate	N/D
Fire fighting	Water self-contained breathing apparatus in confined areas or Procedures when exposed to combustion producers.
Unusual Fire	May form explosive dust-air mixture
Hazardous Combustion Products	Nox, CO2.HCN.I

Health Data

Toxicity : Acute oral LDS : C.5600 mg/kg Tested on RAT

Route of Entry : [ x ] Eye [ x ] Skin [ x ] Ingestion [ x ] Inhalation

Effect of acute exposure

Eye and skin contact will cause irritation. Ingestion will cause adverse health effects. Inhalation will cause irritation of the respiratory tract.

Effects of Chronic Exposure :

There are no known chronic effects associated with this material.

Skin Irritation	Non irritating
Eye Irritation	Irritating
Carcinogenicity	Not Known
Teratogenicity	Not Known
Mutagenicity	Not Known
Exposure limits	Non established
Reproductive Effects	Not Known
Other Health Data	N/D

Production Information

Ventilation : General Mechanical : Adequate Local exhaust :Required Other: N/D

Respiratory Production: Approved dust respirator if dusting occurs.

Gloves: Rubber Plastic

Eyes Protection: Chemical Goggles

Other Protective Measures: Impermeable apron and boots to prevent skin contact

First Aid

Eyes: Flush immediately with water for atleast 15 minutes. Consult a physician immediately.

Skin: Rinse with flowing water for atleast 16 minutes. Consult a physician immediately.

Ingestion : Give water or milk. Do not induce vomiting. Consult a physician immediately.

NoteIf victim is unconscious, never induce vomiting nor given liquids. Place victim in a stable side position and keep warm.

INHALATON: Remove to fresh air. Assist if necessary. Consult a physician

Reactivity Data

Stability : Stable [ x ] Conditions to avoid :

; ; Unstable [ ] Protect from humidity (Product is hygroscopic)

Incompatibility: Excessive heat, reducers

Hazardous Decomposition Products : N/D

Hazardous Polymerization : Conditions to avoid :

May Occur [ ] N/A

Will not Occur[ x ]

Spill & Disposal Procedures

Spill & Leaks :

Sweep up. Avoid generating dust. Do not discharge into neutral waters without pretreatment

Waste Disposal

Dispose of in licensed facility. Observe local regulations.

1-5% aqueous solution, Incinerate in an approved facility, observe local regulations.

Storage & Handling

Avoid Eye & Skin contact. Avoid inhaling. Store in a cool, dry and well ventilated location. Avoid dust generation. Ground and Electrically Bond containers and equipment to prevent electrostatic charges. Protect from moisture.

Ecological Data

Biodegradability	Analysis	Method
	<20% DOC Reduction	OECD 3028/ISO 9888

May cause long-term adverse effect in an aquatic environment

Aquatic Toxicity : LCSO : > 4.6 < 10 mg./1Time : 96 hrs.

Species: Leuciscus idus.

LCO: 5 mg/1 48 : Leuciscus idus.

Inhibition of Bacteria in Effluent :Pseudomonas Putida

17 hrs DIN 38412 part B

No effect :N/D mg/1 : 50% inhibition 380 mg/1

BSE/TSE CERTIFICATE

We herewith declare and certify, that the product Povidone Iodine/Chlorhexidine Gluconate Solution 20%/Chlorhexidine Base manufactured by GLIDE CHEM PVT. LTD. conforms to the following points-

Country of origin is INDIA.
The product contains no ingredients of animal origin.
The product contains no material derived from, or exposed to animal affected by, or under quarantine for Bovine Spongiform Encephalopathy (BSE).
The product is packed in packaging that can be indemnify as to the nature of the products and the country of origin.

IMPURITIES:RESIDUAL SOLVENTS (CPMP/ICH/283/95)

Excipient/Active Substance : Povidone Iodine

Please state whether organic volatile chemical belonging to class 1.2 or 3 are used or product in the manufacture of the actual excipient/active substance:

	YES	NO
Class 1
Class 2
Class3

If the answer is NO for all classes please sign and return the form.

If the answer is YES for Class 1 please complete item a). with the name(s) of the solvent(s) and the maximum content (the highest value obtained among the batches produced) and please attach additional documentatio with the risk benefit assessment.

If the answer is YES for Class 2 please complete item b)with the name(S) of the solvent(s) and state whether it meets option 1 limit (ref. ICII guidelines) or not. For solvents which do not meet option 1 limit give the highest value obtained among the batches produced.

If the answer is YES for class 3 complete itme c) with the name(s) of the solvent(s), and state if the loss of the drying is lower or higher than 0.5%

Item a), Class 1 solvent N.A.

Name Of Solvent	Content (ppm)

Item b), Class 2 Solvnets	N.A.
Name of solvent	Below the option 1 limit	More than option 1 limit
	(If Yes, use the mark X")	(If Yes, give the content,ppm)

Item c), Class 3 solvent	N.A.
Name of solvent	Loss on drying is below 0.5%	Loss on drying is higher than 0.5%
	(If Yes, use the mark X")	If Yes, give the content, ppm)
1.
2.
3.