INTRODUCTION
Atropine sulfate monohydrate is a chemical compound, specifically a salt of atropine and sulfuric acid, with one water molecule (monohydrate) attached. It is commonly used as a medication and in research due to its anticholinergic properties, meaning it blocks the effects of acetylcholine at muscarinic receptors.
MANUFACTURE
The production of Atropine sulfate monohydrate involves several stages — beginning with the extraction of the atropine alkaloid from plants like Atropa belladonna, Datura stramonium, and Hyoscyamus niger, followed by its conversion to atropine sulfate, and finally crystallization into the monohydrate form.
| Synonym | (±)-Tropine tropate sulfate monohydrate |
| CAS no. | 5908-99-6 |
| EINECS no. | 200-235-0 |
| Molecular formula | (C17H23NO3)2 · H2SO4 · H2O |
| Molecular weight | 694.84 |
| Structure |  |
APPLICATIONS
[A] Medical Applications:
| Ophthalmology |
|---|
| Used as a mydriatic (to dilate pupils) and cycloplegic (paralyze ciliary muscle) in eye examinations. |
| Cardiology |
|---|
| Treats bradycardia (abnormally slow heart rate) by increasing heart rate via vagus nerve inhibition. |
| Pre-anesthetic Agent |
|---|
| Reduces saliva and respiratory secretions before surgery. |
| Poisoning Antidote |
|---|
| Critical antidote for organophosphate and nerve agent poisoning (e.g., pesticides, chemical warfare). |
| GI Disorders |
|---|
| Used to relieve intestinal spasms and hypermotility disorders. |
[B] Research & Diagnostics:
| Utilized in autonomic nervous system studies. |
| Employed in pharmacological tests involving muscarinic receptor activity. |
SPECIFICATIONS Ph.Eur
| Test | Unit | Specification |
|---|---|---|
| Appearance | – | White or almost white, crystalline powder or colorless crystals |
| Solubility | – | Very soluble in water, freely soluble in ethanol (96%) |
| Identification | ||
| First Identification a, b and e. OR Second identification c, d, e and f. | ||
| a) Optical rotation | – | Should give positive for optical rotation |
| b) IR | – | Should conform to Ph.Eur |
| c) Picrate derivative test | – | Should give positive for derivative test |
| d) Color test | – | Should give positive for color |
| e) Sulfates | – | Should give positive for sulfate |
| f) Alkaloids | – | Should give positive for alkaloids |
| pH | – | 4.5 – 6.2 |
| Optical rotation | ° | -0.50 to +0.05 |
| Related substance by HPLC | ||
| a) Impurity A | % | NMT 0.2 |
| b) Impurity B | % | NMT 0.2 |
| c) Impurity C | % | NMT 0.2 |
| d) Impurity D | % | NMT 0.2 |
| e) Impurity E | % | NMT 0.3 |
| f) Impurity F | % | NMT 0.2 |
| g) Impurity G | % | NMT 0.2 |
| h) Impurity H | % | NMT 0.3 |
| i) Unspecified impurities | % | NMT 0.10 |
| j) Specified impurities A | % | NMT 0.15 |
| k) Total impurities | % | NMT 0.5 |
| Water | % w/w | 2.0 – 4.0 |
| Sulfated ash | % w/w | Max. 0.1 |
| Assay (by potentiometry) on anhydrous basis | % | 99.0 – 101.0 |
| Residual solvents | ||
| a) Methanol | ppm | NMT 3000 |
| b) Acetone | ppm | NMT 5000 |
| c) Isopropanol | ppm | NMT 5000 |
| d) Methylene dichloride | ppm | NMT 600 |
| e) Ethyl acetate | ppm | NMT 5000 |
| f) Tetrahydrofuran | ppm | NMT 720 |
| g) Toluene | ppm | NMT 890 |
PACKING
25 kg UN approved HDPE drum.
STORAGE
Atropine sulfate is hygroscopic and sensitive to sun light. Store at ambient conditions, well protected from moisture and sun light, away from oxidizing agents.
CERTIFICATION
WHO-GMP, Written Confirmation (WC) and DMF.
ExSyn offers Atropine sulfate on commercial scales and welcomes enquiries. Our exceptional quality and service will make ExSyn your supplier of choice! If you need any additional information or SDS, please contact us.
Glycolaldehyde dimer is the cyclic dimeric form of glycolaldehyde, the simplest hydroxyaldehyde. Glycolaldehyde is often supplied as stable dimeric solid, commonly identified as 2,5-dihydroxy-1,4-dioxane.
N,N-Diisopropylethylamine (DIPEA), also known as Hünig’s Base, is a sterically hindered tertiary amine. It is a colorless liquid with a strong amine odor and is widely used as a low nucleophilic organic base in pharmaceutical, agrochemical, and fine chemical synthesis. Due to its bulky structure, DIPEA effectively scavenges acids without participating in unwanted side reactions.
Tris(2,4-di-tert-butylphenyl) phosphite (TDPP) often recognized commercially as Irgafos 168 is a high-performance organophosphorus compound primarily utilized as secondary antioxidant and processing stabilizer. Its characteristic to undergo metallation reaction and provide a cost-effective synthetic processes allows it to be useful in biaryl coupling reactions.
Undecylenic acid is an unsaturated fatty acid naturally derived from castor oil. It is a colorless to pale yellow liquid with antifungal and antimicrobial properties. Chemically known as 10-undecenoic acid, it contains an 11-carbon chain with one double bond and is widely used in pharmaceuticals
5-Nitro Isophthalic Acid (5-NIPA) is an aromatic organic compound derived from isophthalic acid. The presence of two carboxylic acid groups along with a nitro substituent at the 5-position makes it a valuable intermediate in the manufacture of fine chemicals, pharmaceuticals, dyes, pigments, and advanced materials.
Trichloroacetonitrile is a halogenated organic compound belonging to nitrile family. Its strong electrophilic character makes it a valuable intermediate in organic synthesis. It readily undergoes hydrolysis, particularly under acidic or basic conditions, yielding trichloroacetamide and related derivatives.
Zinc Dialkyl Dithio Phosphate (ZDDP) belongs to a family of coordination compounds classified as members of transition metal dithiophosphate.
ZDDP is widely used based on a combination of different selected alcohols thus providing antiwear performance and enhanced thermal and hydrolytic stability. In combination with other additives, it is especially used for the formulation of hydraulic fluids, industrial gear oils, metalworking fluids, greases and automotive engine oils.
Dibutyl sulfide is an organosulfur. It is a clear, colorless to pale yellow liquid characterized by a strong sulfur-like odor and is primarily used as an intermediate in chemical synthesis, specialty organic manufacturing, and research applications. The compound exhibits good solvency properties and moderate thermal stability, making it useful in industrial and laboratory processes involving sulfur-containing organic compounds.
Oleylamine is a long-chain (C18) primary fatty amine derived from natural fatty acids, typically sourced from vegetable oils. It is produced from oleic acid through conversion of the carboxylic acid group (–COOH) into an amine group (–NH₂). With its optimal balance of hydrophobic chain length and reactive amine functionality it serves as a versatile and dependable building block for high-performance formulations.