Sulfadoxine is a long acting sulfonamide used for the treatment or prevention of malaria.
Sulfadoxine is used in combination with pyrimethamine for the treatment or prevention of malaria. It can also be used to treat various infections in livestock as well. Sulfadoxine and pyrimethamine is indicated for the treatment of Plasmodium falciparum malaria in those patients in whom chloroquine resistance is suspected.
Certificate of Analysis
| Test | Specification | Results |
| Description | White or yellowish white crystals or crystalline powder. | White crystalline powder |
| Solubility | Very slightly soluble in water, slightly soluble in alcohol and in methanol. | Complies |
| Identification | ||
| A) By IR | The IR absorption spectrum of the test sample should be concordant with that of sulphadoxine standard. | Comparable |
| B) By TLC | The principal spot in the chromatogram obtained with the test solution corresponds to the chromatogram obtained of reference solution | Complies |
| C) By Chemically | The residue melts either at 800C to 820C or at 900C to 920C. | 80.50C – 81.10C |
| D) By Chemically | The resulting solution given reaction of primary aromatic amines. | Complies |
| Appearance of Solution | The solution is not more intensely colored than ref. solution YS5, BYS5 or GYS5. | Complies |
| Acidity | Not more than 0.2 mL of 0.1 M sodium hydroxide is required to change the colour of solution. | Complies |
| Related substance by TLC | Any secondary spot in the chromatogram obtained with the test solution is not more intense than that spot in chromatograph obtained with reference solution (b). (0.5%) | Complies |
| Heavy Metals | NMT 20 ppm | Complies |
| Loss on drying | NMT 0.5 % | 0.32 % |
| Assay by titration | NLT 99.0 % & NMT 101.0% | 100.8 % |
Material Safety Data Sheet
SECTION 1 – CHEMICAL PRODUCT AND COMPANY IDENTIFICATION
MSDS Identification Name : Sulfadoxin
Supplier : ATILUS PHARMA PVT. LTD.
SECTION 2 – COMPOSITION, INFORMATION ON INGREDIENTS
| CAS # | Chemical Name | % | EINECS # |
| 2447-57-6 | Benzenesulfonamide, 4-amino-N-(5,6-dimethoxy-4-pyrimidinyl)-; N-(5,6-Dimethoxy-4-pyrimidinyl) sulfanilamide | <=100 | 219-504-9 |
Synonyms : Benzenesulfonamide, 4-amino-N-(5,6-dimethoxy-4-pyrimidinyl)-;
N-(5,6-Dimethoxy-4-pyrimidinyl) sulfanilamide
Formula : C12H14N4O4S
Molecular weight : 310.3 g/mol
SECTION 3 – HAZARDS IDENTIFICATION
3.1 Classification of the substance or mixture
Classification according to Regulation (EC) No 1272/2008
Skin sensitization (Category 1), H317 Long-term (chronic) aquatic hazard (Category 2), H411 For the full text of the H-
For the full text of the H-Statements mentioned in this Section, see Section 16.
3.2 Label elements
Labelling according Regulation (EC) No 1272/2008
Pictogram
Signal word Warning
Hazard statement(s)
Hazard statement(s)
H317 May cause an allergic skin reaction.
H411 Toxic to aquatic life with long lasting effects.
Precautionary statement(s)
P261 Avoid breathing dust/ fume/ gas/ mist/ vapors/ spray.
P272 Contaminated work clothing should not be allowed out of the workplace.
P273 Avoid release to the environment.
P280 Wear protective gloves.
P302 + P352 IF ON SKIN: Wash with plenty of water.
P333 + P313 If skin irritation or rash occurs: Get medical advice/ attention.
Supplemental Hazard Statements None
Reduced Labeling (<= 125 ml)
Pictogram
Signal Word Warning
Hazard statement(s) H317 May cause an allergic skin reaction.
Precautionary statement(s)
P261 Avoid breathing dust/ fume/ gas/ mist/ vapors/ spray.
P272 Contaminated work clothing should not be allowed out of the workplace.
P280 Wear protective gloves.
P302 + P352 IF ON SKIN: Wash with plenty of water.
Supplemental Hazard Statements
P333 + P313 If skin irritation or rash occurs: Get medical advice/ attention.
Supplemental Hazard Statements None
3.3 Other hazards
This substance/mixture contains no components considered to be either persistent, bioaccumulative and toxic (PBT), or very persistent and very bioaccumulative (vPvB) at levels of 0.1% or higher. Caution: Physiologically highly active, therapeutically usable substance. The substance must be handled with the care required for hazardous materials.
SECTION 4 – FIRST AID MEASURES
4.1 Description of first-aid measures
General advice
Show this material safety data sheet to the doctor in attendance.
If inhaled
After inhalation: fresh air. Consult doctor if feeling unwell.
In case of skin contact
In case of skin contact: Take off immediately all contaminated clothing. Rinse skin with water/ shower. Consult a physician.
In case of eye contact After eye contact:
rinse out with plenty of water. Remove contact lenses.
If swallowed
After swallowing: immediately make victim drink water (two glasses at most). Consult a physician.
4.2 Most important symptoms and effects, both acute and delayed
The most important known symptoms and effects are described in the labelling (see section
2.2) and/or in section 11
4.3 Indication of any immediate medical attention and special treatment needed
No data available
SECTION 5 – FIRE FIGHTING MEASURES
5.1 Extinguishing media
Suitable extinguishing media
Water Foam Carbon dioxide (CO2) Dry powder
Unsuitable extinguishing media
For this substance/mixture no limitations of extinguishing agents are given.
5.2 Special hazards arising from the substance or mixture
Carbon oxides Nitrogen oxides (NOx) Sulfur oxides Combustible.
Development of hazardous combustion gases or vapours possible in the event of fire.
5.3 Advice for firefighters Stay in danger area only with self-contained breathing apparatus. Prevent skin contact by keeping a safe distance or by wearing suitable protective clothing.
5.4 Further information
Suppress (knock down) gases/vapors/mists with a water spray jet. Prevent fire extinguishing water from contaminating surface water or the ground water system.
SECTION 6 – ACCIDENTAL RELEASE MEASURES
6.1 Personal precautions, protective equipment and emergency procedures Advice for non-Advice for non-emergency personnel: Avoid inhalation of dusts. Avoid substance contact. Ensure adequate ventilation. Evacuate the danger area, observe emergency procedures, consult an expert. For personal protection see section 8.
6.2 Environmental precautions
Do not let product enter drains.
6.3 Methods and materials for containment and cleaning up
Cover drains. Collect, bind, and pump off spills. Observe possible material restrictions (see sections 7 and 10). Take up dry. Dispose of properly. Clean up affected area. Avoid generation of dusts.
6.4 Reference to other sections
For disposal see section 13.
SECTION 7 – HANDLING AND STORAGE
7.1 Precautions for safe handling
For precautions see section 2.2.
7.2 Conditions for safe storage, including any incompatibilities
Storage conditions Tightly closed. Dry.
Storage stability Recommended storage temperature 2 – 8 °C
Storage class Storage class (TRGS 510): 11: Combustible Solids
7.3 Specific end use(s) Apart from the uses mentioned in section 1.2 no other specific uses are stipulated
SECTION 8 – EXPOSURE CONTROLS, PERSONAL PROTECTION
8.1 Control parameters
Ingredients with workplace control parameters
8.2 Exposure controls
Personal protective equipment
Eye/face protection
Use equipment for eye protection tested and approved under appropriate government standards such as NIOSH (US) or EN 166(EU). Safety glasses
Skin protection
This recommendation applies only to the product stated in the safety data sheet, supplied by us and for the designated use. When dissolving in or mixing with other substances and under conditions deviating from those stated in EN374 please contact the supplier of CE-approved gloves (e.g. KCL GmbH, D-36124 Eichenzell, Internet: www.kcl.de). Body Protection
Full contact Material: Nitrile rubber
Minimum layer thickness: 0,11 mm
Break through time: 480 min
Material tested:KCL 741 Dermatril® L
Splash contact Material: Nitrile rubber
Minimum layer thickness: 0,11 mm
Break through time: 480 min Material tested:KCL 741 Dermatril® L
Body Protection protective clothing
Respiratory protection
required when dusts are generated. Our recommendations on filtering respiratory protection are based on the following standards: DIN EN 143, DIN 14387 and other accompanying standards relating to the used respiratory protection system. Recommended Filter type: Filter type P3
The entrepeneur has to ensure that maintenance, cleaning and testing of respiratory protective devices are carried out according to the instructions of the producer. These measures have to be properly documented.
Control of environmental exposure
Do not let product enter drains.
SECTION 9 – PHYSICAL AND CHEMICAL PROPERTIES
9.1 Information on basic physical and chemical properties
- a) Appearance Form : Solid
- b) Odor : Not applicable
- c) Odor : Not applicable
- d) pH : No data available
- e) n) Partition coefficient: n-octanol/water : log Pow: 0,7 at 20 °C – Bioaccumulation is not expected.
- f) Autoignition :No data available
temperature
- g) Melting point: 197 °C point/freezing point
- h) Viscosity Viscosity, kinematic : No data available
Viscosity, dynamic : No data available
- i) Explosive properties : No data available
- j) Oxidizing properties :No data available
9.2 Other safety information
No data available
SECTION 10 – STABILITY AND REACTIVITY
10.1 Reactivity
The following applies in general to flammable organic substances and mixtures: in correspondingly fine distribution, when whirled up a dust explosion potential may generally be assumed.
10.2 Chemical stability
The product is chemically stable under standard ambient conditions (room temperature) .
10.3 Possibility of hazardous reactions
no information available
10.4 Conditions to avoid
no information available
10.5 Incompatible materials
No data available
10.6 Hazardous decomposition products
In the event of fire: see section 5
SECTION 11 – TOXICOLOGICAL INFORMATION
11.1 Information on toxicological effects
Acute toxicity LD50 Oral – Mouse – 5.200 mg/kg
Remarks: (RTECS)
Inhalation: Irritating to respiratory system.
Dermal: No data available
Skin corrosion/irritation
No data available
Serious eye damage/eye irritation
No data available
Respiratory or skin sensitization
No data available
Germ cell mutagenicity
No data available
Carcinogenicity
This product is or contains a component that is not classifiable as to its carcinogenicity based on its IARC, ACGIH, NTP, or EPA classification.
Reproductive toxicity Animal experiments have shown that multiple malformations can be induced using pyrimethamine while human studies have found pyrimethamine does not increase the risk of abnormalities during pregnancy.
Specific target organ toxicity – single exposure
No data available
Specific target organ toxicity – repeated exposure
No data available
Aspiration hazard No data available
11.2 Additional Information Endocrine disrupting properties Product:
Assessment :
The substance/mixture does not contain components considered to have endocrine disrupting properties according to REACH Article 57(f) or Commission Delegated regulation (EU) 2017/2100 or Commission Regulation (EU) 2018/605 at levels of 0.1% or higher.
RTECS: DA9500000 To the best of our knowledge, the chemical, physical, and toxicological properties have not been thoroughly investigated.
SECTION 12 – ECOLOGICAL INFORMATION
12.1 Toxicity
No data available
12.2 Persistence and degradability
No data available
12.3 Bioaccumulative potential
No data available
12.4 Mobility in soil
No data available
12.5 Results of PBT and vPvB assessment
This substance/mixture contains no components considered to be either persistent,
bioaccumulative and toxic (PBT), or very persistent and very bioaccumulative (vPvB) at
levels of 0.1% or higher.
12.6 Endocrine disrupting properties
Product: Assessment : The substance/mixture does not contain components
considered to have endocrine disrupting properties according to REACH Article 57(f) or Commission Delegated regulation (EU) 2017/2100 or Commission Regulation (EU) 2018/605 at levels of 0.1% or higher.
12.7 Other adverse effects
No data available
SECTION 13 – DISPOSAL CONSIDERATIONS
13.1 Waste treatment methods
Product
No data available
SECTION 14 – TRANSPORT INFORMATION
14.1 UN number
UN number ADR/RID: 3077 IMDG: 3077 IATA: 3077
14.2 UN proper shipping name
ADR/RID: ENVIRONMENTALLY HAZARDOUS SUBSTANCE, SOLID, N.O.S. (Sulfadoxine) IMDG: ENVIRONMENTALLY HAZARDOUS SUBSTANCE, SOLID, N.O.S. (Sulfadoxine) IATA: Environmentally hazardous substance, solid, n.o.s. (Sulfadoxine)
14.3 Transport hazard class(es)
ADR/RID: 9 – IMDG: – 9 IATA: – 9
14.4 Packaging group
ADR/RID: -III IMDG: – III IATA: – III
14.5 Environmental hazards
ADR/RID: yes IMDG Marine pollutant: yes IATA: yes
14.6 Special precautions for user
Tunnel restriction code : (-)
Further information
Further information
EHS-Mark required (ADR 2.2.9.1.10, IMDG code 2.10.3) for single packagings and combination packagings containing inner packagings with Dangerous Goods > 5L for liquids or > 5kg for solids.Packages smaller than or equal to 5 kg / L , not dangerous goods of Class 9
SECTION 15 – REGULATORY INFORMATION
15.1 Safety, health and environmental regulations/legislation specific for the
substance or mixture
This material safety data sheet complies with the requirements of Regulation (EC) No.
1907/2006.
National legislation
Seveso III: Directive 2012/18/EU of the European Parliament and of the Council on the control of
major-accident hazards involving dangerous substances.
Other regulations
Observe work restrictions regarding maternity protection in accordance to Dir 92/85/EEC or stricter national regulations where applicable.
15.2 Chemical Safety Assessment
For this product a chemical safety assessment was not carried out
SECTION 16 – ADDITIONAL INFORMATION
The information above is believed to be accurate and represents the best information currently available to us. However, we make no warranty of merchantability or any other warranty, express or implied, with respect to such information, and we assume no liability resulting from its use. Users should make their own investigations to determine the suitability of the information for their particular purposes. In no way shall the company be liable for any claims, losses, or damages of any third party or for lost profits or any special, indirect, incidental, consequential or exemplary damages, howsoever arising, even if the company has been advised of the possibility of such damages.
