POVIDONE IODINE USP/ 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 USP ( Current Edition)
 
MATERIAL SAFETY DATA SHEET
POVIDONE IODINE USP/ BP/ EP

SECTION I
    Trade name: PVP - Iodine
    Synonyms: N/A
    Chemical Identity : Polyvinylpyrrolidone-Iodine Complex
    Use: Chemical Intermediate
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 - Stable.
    Incompatibility - Solutions containing inorganic anions such as saline.
    Decomposition - N/A
    Polymerization - Polymerization will not occur.

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. 

Note :   If 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.