Fluvoxamine is used to treat obsessive-compulsive disorder (OCD). It helps decrease thoughts that are unwanted or that don’t go away (obsessions), and it helps to reduce the urge to perform repeated tasks (compulsions such as hand-washing, counting, checking) that interfere with daily living.
Certificate of Analysis
| Test | Specification | Results |
| Description | White to off- white crystalline powder. | White crystalline powder. |
| Solubility
| Freely soluble in ethanol (95%) and methanol. Sparingly soluble in water. | Complies |
| Identification | ||
| By IR | The Infrared spectrum of the sample should be corresponded with that of IR spectrum of the Working standard. | Complies |
| Related substances | ||
| Impurity B | Not more than 0.5 % | Not Detected |
| Impurity C | Not more than 0.3 % | Not Detected |
| Impurity A | Not more than 0.2 % | Not Detected |
| Impurity D | Not more than 0.15 % | Not Detected |
| Impurity F & G | Not more than 0.3 % | 0.05 % |
| Unspecified Impurity | Not more than 0.1 % | 0.04 % |
| Total impurities | Not more than 1.0 % | 0.23 % |
| Loss on drying | Not more than 0.5 % | 0.3 % |
| Heavy metal | Not more than 20 ppm | Complies |
| Sulfated ash | NMT 0.1 % | 0.04 % |
| Assay By potentiometry | Not less than 99.0 % and not more than 101.0% (Dried Substance). | 100.2 % |
Material Safety Data Sheet
SECTION 1 – CHEMICAL PRODUCT AND COMPANY IDENTIFICATION
MSDS Identification Name : Fluvoxamine Maleate
Supplier : ATILUS PHARMA PVT. LTD.
SECTION 2 – COMPOSITION, INFORMATION ON INGREDIENTS
| CAS # | Chemical Name | % | EINECS # |
| 61718-82-9 | (E)-5-Methoxy-1-[4-(trifluoromethyl)phenyl]-1-pentanone-O- (2-aminoethyl)oxime maleate | <=100 | -s |
Synonyms : (E)-5-Methoxy-1-[4-(trifluoromethyl)phenyl]-1-pentanone-O- (2-aminoethyl)oxime maleate
Formula : C15H21F3N2O2 · C4H4O4
Molecular weight : 434.41 g/mol
SECTION 3 – HAZARDS IDENTIFICATION
3.1 Classification of the substance or mixture
Classification according to Regulation (EC) No 1272/2008
Acute toxicity, Oral (Category 4), H302
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) H302 Harmful if swallowed.
Hazard statement(s)
H302 Harmful if swallowed.
Precautionary statement(s)
P301 + P312 + P330 IF SWALLOWED: Call a POISON CENTER/ doctor if you feel unwell. Rinse mouth. 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.
SECTION 4 – FIRST AID MEASURES
4.1 Description of first-aid measures
General advice
Consult a physician. Show this material safety data sheet to the doctor in attendance.
After inhalation:
If breathed in, move person into fresh air. If not breathing, give artificial respiration. Consult a physician.
In case of skin contact
Wash off with soap and plenty of water. Consult a physician.
If swallowed
After swallowing: immediately make victim drink water (two glasses at most). Consult a physician.
In case of eye contact
Flush eyes with water as a precaution. If swallowed Never give anything by mouth to an unconscious person. Rinse mouth with water. 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
Use water spray, alcohol-resistant foam, dry chemical or carbon dioxide.
5.2 Special hazards arising from the substance or mixture Carbon oxides Nitrogen oxides Carbon oxides Nitrogen oxides (NOx) Hydrogen fluoride
5.3 Advice for firefighters
Wear self-contained breathing apparatus for firefighting if necessary.
5.4 Further information
No data available
SECTION 6 – ACCIDENTAL RELEASE MEASURES
6.1 Personal precautions, protective equipment and emergency procedures 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
Pick up and arrange disposal without creating dust. Sweep up and shovel. Keep in suitable, closed containers for disposal.
6.4 Reference to other sections
For disposal see section 13.
SECTION 7 – HANDLING AND STORAGE
7.1 Precautions for safe handling
Advice on safe handling
Avoid contact with skin and eyes. Avoid formation of dust and aerosols.
Advice on protection against fire and explosion
Provide appropriate exhaust ventilation at places where dust is formed.
Hygiene measures
Handle in accordance with good industrial hygiene and safety practice. Wash hands before breaks and at the end of workday. For precautions see section 2.2.
7.2 Conditions for safe storage, including any incompatibilities
Storage conditions
Keep container tightly closed in a dry and well-ventilated place. Store in cool place.
Storage stability Recommended storage temperature 2 – 8 °C
Storage class
Storage class (TRGS 510): 13: Non 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
Eye/face protection
Safety glasses with side-shields conforming to EN166 Use equipment for eye protection tested and approved under appropriate government standards such as NIOSH (US) or EN 166(EU).
Skin protection
Handle with gloves. Gloves must be inspected prior to use. Use proper glove removal technique (without touching glove’s outer surface) to avoid skin contact with this product. Dispose of contaminated gloves after use in accordance with applicable laws and good laboratory practices. Wash and dry hands. The selected protective gloves have to satisfy the specifications of Regulation (EU) 2016/425 and the standard EN 374 derived from it. Full contact Material: Nitrile rubber Minimum layer thickness: 0,11 mm Break through time: 480 min Material tested:Dermatril® (KCL 740 / Aldrich Z677272, Size M) Splash contact Material: Nitrile rubber Minimum layer thickness: 0,11 mm Break through time: 480 min Material tested:Dermatril® (KCL 740 / Aldrich Z677272, Size M) data source: KCL GmbH, D-36124 Eichenzell, phone +49 (0)6659 87300, e-mail sales@kcl.de, test method: EN374 If used in solution, or mixed with other substances, and under conditions which differ from EN 374, contact the supplier of the EC approved gloves. This recommendation is advisory only and must be evaluated by an industrial hygienist and safety officer familiar with the specific situation of anticipated use by our customers. It should not be construed as offering an approval for any specific use scenario.
Body Protection
Complete suit protecting against chemicals, The type of protective equipment must be selected according to the concentration and amount of the dangerous substance at the specific workplace.
Respiratory protection
For nuisance exposures use type P95 (US) or type P1 (EU EN 143) particle respirator.For higher level protection use type OV/AG/P99 (US) or type ABEK-P2 (EU EN 143) respirator cartridges. Use respirators and components tested and approved under appropriate government standards such as NIOSH (US) or CEN (EU).
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) Melting point/freezing point Melting point/range: No data available
- f) Autoignition :No data available
temperature
- g) Decomposition temperature :No data available
- 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 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.
10.3 Possibility of hazardous reactions
Violent reactions possible with:
Strong oxidizing agents
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 – 1.100 mg/kg Remarks: Sense Organs and Special Senses (Nose, Eye, Ear, and Taste):Eye:Mydriasis (pupilliary dilation). Behavioral:Convulsions or effect on seizure threshold. Behavioral:Ataxia.
Inhalation: No data available
Dermal: No data available
Skin corrosion/irritation
Remarks: No data available
Serious eye damage/eye irritation
Remarks: No data available
Respiratory or skin sensitization
No data available
Germ cell mutagenicity No data available
Carcinogenicity No data available
Reproductive toxicity
No data available
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
RTECS: SA9230000 Nausea, Dizziness, Headache To the best of our knowledge, the chemical, physical, and toxicological properties have not been thoroughly investigated.
SECTION 12 – ECOLOGICAL INFORMATION
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 Other adverse effects
No data available
SECTION 13 – DISPOSAL CONSIDERATIONS
13.1 Waste treatment methods
Product
Product Offer surplus and non-recyclable solutions to a licensed disposal company. Dissolve or mix the material with a combustible solvent and burn in a chemical incinerator equipped with an afterburner and scrubber. Waste material must be disposed of in accordance with the Directive on waste 2008/98/EC as well as other national and local regulations. Leave chemicals in original containers. No mixing with other waste. Handle uncleaned containers like the product itself
Contaminated packaging
Dispose of as unused product.
SECTION 14 – TRANSPORT INFORMATION
14.1 UN number
ADR/RID: – IMDG: – IATA: –
14.2 UN proper shipping name
ADR/RID: Not dangerous goods
IMDG: Not dangerous goods
IATA: Not dangerous goods
14.3 Transport hazard class(es)
ADR/RID: – IMDG: – IATA: –
14.4 Packaging group
ADR/RID: – IMDG: – IATA: –
14.5 Environmental hazards
ADR/RID: no IMDG Marine pollutant: no IATA: no
14.6 Special precautions for user
Further information
Not classified as dangerous in the meaning of transport regulations.
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. :Not applicable
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.
