API Products

Pharmacopia:USP, BP
Industrial Applications:Pharmaceutical   
category:analgesic, pain management
Codeine phosphate monohydrate is from  a  category  of opioids which target the opioid receptors..
Opioids mimmick the andogen peptide effect on the Miu, Capa and Delta receptors.It is usually formulated with NSAID,s to enhance its effect in pain management.Its crystalline form fascilitates its free flowing  and easy compressibility in tabletting process. .
Physical Characteristics:
Molecular formula: C18H21NO3.H3PO4.1/2H2O
Molecular weight: 406.4
Appearance: White or almost white, crystalline powder or small. colourless crystals.
Solubility: Freely soluble in water, slightly soluble or very  slightly soluble in ethanol (96 percent).
Melting point: 155 – 159 °C
pH: 4.0 – 5.0
Water: Maximum 3.0 %
Chloride: No opalescence is produced immediately.
Specific optical rotation: -98 to -102 (dried substance).
Purity: Minimum 98.0%.
Assay: 98.5% to 101.0% (anhydrous basis).
Storage: Protected from light.
Stability: Stable at least 2 years at R.T
Pharmacopia:USP, BP
Industrial Applications:Pharmaceutical   
category: Addiction therapy

Methadone  is a synthetic opioid whis the major drug used in addiction therapy and maintenance therapy.Methadone has no metabolite.Its plasma concentration lasts 6-8 hours and increases on extended use.Its onset effect is within 0.5-1 hour and lasts for 12 hours on extended use.Its unique crystalline form is an added value in the manufacturing process..  . 

Physical Characteristics:
Molecular formula: C21H28ClNO
Molecular weight: 345.9
Appearance: White or almost white, crystalline powder.
Solubility: Soluble in water, freely soluble in ethanol (96%).
Melting point: 233 – 236 °C
pH : 4.5 – 6.5
Water: Maximum 0.5% (105 °C)
Optical rotation: Between -0.05° to +0.05°.
Sulfated ash: Maximum 0.1%
Purity: Minimum 99.7%.
Assay: 99.0 per cent to 101.0 per cent (dried substance).
Storage: protected from light.
Stability: Stable at least 2 years at R.T
Pharmacopia:USP, BP
Industrial Applications:Pharmaceutical   
category: Pain management

Opioids are natural and synthetic compositions which targt the miu, capa and delta endogen opioid receptors . Ondogens  employ pain relief  intermediatory acts on these receptors.Opioids mimmics the peptids effect on these receptors.Intensity of pain, route of administration, duration of usage of patient are suitable for selection of the type of the right opioids. .Oxycodone , a semi synthetic opioid is used medically for treatment of moderate to severe pain and alson has other non-analgesic effects on the respiratory and is also known as a cough suppressant.

Physical Characteristics:
Molecular formula: C18H22ClNO4
Molecular weight: 351.82
Appearance: White or almost white powder, hygroscopic.
Solubility: Freely soluble in water, sparingly soluble in anhydrous ethanol, practically insoluble in toluene.
Water: Maximum 7.0%
Residue on ignition: Maximum 0.05%.
Specific optical rotation: Between -140 to -148.
Sulfated ash: Maximum 0.1%
Ethanol: Maximum 1.0%
Purity: Minimum 98.5%.
Assay: 98.5% to 101.5% (dried substance).
Storage: In an airtight containers. protected from light.
Stability: Stable at least 2 years at R.T
Pharmacopia:USP, BP
Industrial Applications:Pharmaceutical   
category: Pain management
Opioids are natural and synthetic compositions which targt the miu, capa and delta endogen opioid receptors . Ondogens  employ pain relief  intermediatory acts on these receptors.Opioids mimmics the peptids effect on these receptors.Intensity of pain, route of administration, duration of usage of patient are suitable for selection of the type of the right opioid.Morphine sulphate is indicated for the relief of chronic, persistent severe pain . . .
Physical Characteristics:
Molecular formula: C34H40N2O10S,5H2O
Molecular weight: 759
Appearance: White or almost white, crystalline powder.
Solubility: Soluble in water, very slightly soluble in ethanol (96 per cent), practically insoluble in toluene.
Water: 10.4% to 13.4%
Specific optical rotation: -107 to -110 (anhydrous substance).
Residue on ignition: Maximum 0.1%.
Sulfated ash: Maximum 0.1%.
Chloride: No precipitate or turbidity is produced immediately.
Ammonium salts: No odor of ammonia is perceptible.
Iron: Maximum 5 PPM.
Limit of foreign alkaloids: NLT 7.5 mL is required (1.5%).
Purity: Minimum 99.0%.
Assay: 98.0% to 102.0%.
Storage: Protected from light.
Stability: Stable at least 2 years at R.T
Pharmacopia:BP, USP, IP
Industrial Applications:Pharmaceutical   
category:addiction therapy

Buprenorphine is an opioid antagonist which is used mainly for opioid addiction to reduce cravings and withdrawal symptoms without causing euphoria or dangerous side effects and helps prevent relapse with minimal discomfort .

        
Physical Characteristics:      
Molecular formula: C29H42ClNO4      
Molecular weight: 504.1      
Appearance: White or almost white, crystalline powder.      
Solubility: Sparingly soluble in water, freely soluble in methanol, soluble in ethanol (96 per cent), practically insoluble in cyclohexane.      
Heavy metals: Maximum 20 ppm      
Water: Maximum 1.0 %      
Specific optical rotation: -92 to -98 (dried substance).      
Sulfated ash: Maximum 0.2%.      
Purity: Minimum 99.3%.      
Assay: 98.5 per cent to 101.5 per cent (dried substance).      
Storage: Protected from light.      
Stability: Stable at least 2 years at R.T      
Pharmacopia:BP, USP
Industrial Applications:Pharmaceutical   
category: Addiction therapy
Naltrexone is an opioid antagonist which is used in opioid and alcohol use disorder .It reduces cravings and helps control physiological dependace. Naltrexone works by blocking the effects of alcohol and opioid medications , preventing euphoria and intoxication and relapses.  
        
Physical Characteristics:      
Molecular formula: C20H24ClNO4      
Molecular weight: 377.9      
Appearance: White or almost white powder, very hygroscopic.      
Solubility: Freely soluble in water, slightly soluble in ethanol (96 per cent), practically insoluble in methylene chloride.      
Water: Maximum 10.0%      
Specific optical rotation: -187 to -195 (anhydrous substance).      
Sulfated ash: Maximum 0.1%      
Ethanol: Maximum 3.0%      
Content of chloride: 9.20%–9.58%, calculated on the anhydrous, solvent-free basis.      
Residue on ignition: Maximum 0.1%      
Purity: Minimum 99.0%.      
Assay: 98.0% to 102.0% (anhydrous substance).      
Storage: In an airtight container. Protected from light.      
Stability: Stable at least 2 years at R.T      
Pharmacopia:USP, BP
Industrial Applications:Pharmaceutical   
category: Pain management

tramadol is an opioid agonist which is being used to treat moderate to severe chronic pain in adults.extended release form of tramadol is used for around- the- clock treatment for long term treatment.. It works on the same proteins in the brain as morphine does.

        
Physical Characteristics:      
Molecular formula: C16H26ClNO2      
Molecular weight: 299.8      
Appearance: White or almost white, crystalline powder.      
Solubility: Freely soluble in water and in methanol, very slightly soluble in acetone.      
Melting point: 180 -184 °C      
Water: Maximum 0.5%      
Optical rotation: -0.10° to +0.10°.      
Sulfated ash: Maximum 0.1%      
Content of chloride: 11.6%–12.1% of chloride is found.      
Residue on ignition: Maximum 0.1%      
Purity: Minimum 99.6%.      
Assay: 99.0% to 101.0% (anhydrous substance).      
Storage: Protected from light.      
Stability: Stable at least 2 years at R.T      
Pharmacopia:BP, USP
Industrial Applications:Pharmaceutical   
category: Opioid overdose antidote

Naloxone  is a FDA approved medicine used to quickly reverse an opioid overdose and is  an opioid antagonist which is used in opioid  use disorder . Naloxone works by blocking the opioid receptors and therefore reverses and blocks the effects of other opioids. Naloxone should be used as soon as possible to treat a known or  suspected overdose.. Naloxone is a synthetic cogener of oxymorphone

        
Physical Characteristics:      
Molecular formula: C19H22ClNO4,2H2O      
Molecular weight: 399.9      
Appearance: White or almost white, hygroscopic, crystalline powder.      
Solubility: Freely soluble in water, soluble in ethanol (96 per cent), practically insoluble in toluene.      
Water: 7.5% to 11.0%      
Specific optical rotation: -181 to -170 (anhydrous substance).      
Sulfated ash: Maximum 0.2%      
Content of chloride: 9.54%–9.94% on the dried basis.      
Purity: Minimum 99.2%.      
Assay: 98.0% to 102.0% (anhydrous substance).      
Storage: In an airtight container, protected from light.      
Stability: Stable at least 2 years at R.T      
Pharmacopia:EP, BP
Industrial Applications:Pharmaceutical   
category:pain management
Morphine is used to treat moderate to severe pain when alternative pain relief medicines are not effective or not tolerated.Morphine is an opioid pain relieving medication that usually provides significant pain relief for short term or chronic pain. .It belongs to a class of medications called opiate (narcotic) analgesics
        
Physical Characteristics:      
Molecular formula: C17H20ClNO3,3H2O      
Molecular weight: 375.8      
Appearance: White or almost white, crystalline powder or colourless, silky needles or cubical masses, efflorescent in a dry atmosphere.      
Solubility: Soluble in water, slightly soluble in ethanol (96 per cent), practically insoluble in toluene.      
Water: 12.5% to 15.5%      
Specific optical rotation: -110 to -115 (anhydrous substance).      
Sulfated ash: Maximum 0.1%.      
Purity: Minimum 99.0%.      
Assay: 98.0% to 102.0% (anhydrous substance).      
Storage: Protected from light.      
Stability: Stable at least 2 years at R.T      
Pharmacopia:JP
Industrial Applications:Pharmaceutical   
category:pain management

Dihydrocodeine phosphate is an opioid analgesic or adjunct to codeine to treat moderate to severe pain, severe dyspnea and cough:

 

        
Physical Characteristics:      
Molecular formula: C18H23NO3.H3PO4      
Molecular weight: 399.38      
Appearance: White to yellowish white crystalline powder.      
Solubility: Freely soluble in water and in acetic acid (100), slightly soluble in ethanol (95), and practically insoluble in diethyl ether.      
pH : Between 3.0 and 5.0.      
Chloride: Maximum 0.021%.      
Sulfate: Maximum 0.024%.      
Water: Maximum 1.0%. (105 °C)      
Assay: Minimum 98.0%  (dried basis).      
Storage: Containers Tight containers. Storage Light-resistant.      
Stability: Stable at least 2 years at R.T      
Pharmacopia:BP, USP
Industrial Applications:Pharmaceutical   
category: Pain management

Hydrocodone is used to treatment of severe chronic pain and is usually used in combination formulations to treat nonproductive cough in adults and has antitussive properties.

        
Physical Characteristics:      
Molecular formula: C18H21NO3.C4H6O6.2 1/2 H2O      
Molecular weight: 494.5      
Appearance: White or almost white, hygroscopic, crystalline powder.      
Solubility: Freely soluble or soluble in water, sparingly soluble in ethanol (96%), practically insoluble in cyclohexane.      
pH: 3.2 to 3.8      
Water: 7.0% to 12.0%.      
Specific optical rotation: -87° to -91°(anhydrous substance).      
Sulfated ash: Maximum 0.1%      
Purity: Minimum 99.0%.      
Assay: 99.0% to 101.0% (anhydrous substance).      
Storage: In an airtight container. Protected from light.      
Stability: Stable at least 2 years at R.T      
Pharmacopia:JP
Industrial Applications:Pharmaceutical   
category:pain management

Dihydrocodeine phosphate is an opioid analgesic or adjunct to codeine to treat moderate to severe pain, severe dyspnea and cough:

 

        
Physical Characteristics:      
Molecular formula: C18H23NO3.H3PO4      
Molecular weight: 399.38      
Appearance: White to yellowish white crystalline powder.      
Solubility: Freely soluble in water and in acetic acid (100), slightly soluble in ethanol (95), and practically insoluble in diethyl ether.      
pH : Between 3.0 and 5.0.      
Chloride: Maximum 0.021%.      
Sulfate: Maximum 0.024%.      
Water: Maximum 1.0%. (105 °C)      
Assay: Minimum 98.0%  (dried basis).      
Storage: Containers Tight containers. Storage Light-resistant.      
Stability: Stable at least 2 years at R.T      
Pharmacopia:USP
Industrial Applications:addiction therapyPharmaceutical   
category:opiate Agonist & antiperistatic agent(addiction therapy, Diarrhea treament)

Opium tincture or laudanum is a tincture of opium containing approximately 10 % powdered raw opium by weight but affirmatively 1% of morphine.originall it was used for treatment of diarrhea but safe and efficacious for people with opioid used disorder anf in particular  for opium use disorder:

 

        
Physical Characteristics:      
Appearance: Dark brown liquid.      
Alcohol content: 17.0% to 21.0% of ethanol.      
Assay: 0.90% to 1.10% of anhydrous morphine.      
Microbiological tests:
– Not more than 10^2CFU of bile-tolerant gram negative bacteria (1g or 1ml).
– Absent of Salmonella (10g or 10ml).
– Absent of Escherichia coli (1g or 1ml).
– Absent of Staphylococcus aureus (1g or 1ml).
– Total aerobic microbial count: NMT 10^4 CFU/ml.
– Total combinedyeasts and molds count: NMT 10^2CFU/ml.		      
Storage: Preserve in tight, light-resistant containers, and avoid exposure to direct sunlight and to excessive heat. Store in room temperature.      
Stability: Stable at least 2 years at R.T      
Pharmacopia:BP
Industrial Applications:Pharmaceutical   
category:short term anaesthetic and analgesic

remifentanil,  a synthetic opioid used for inducing anaesthesia  and analgesic  with a short effect .it has a very short recovery time. Remifentail is a  selective miu receptor antagonist therefore lowers the symphatic neuronal tone , bronchial suppression, analgesic effects.its effect is rapid, very short term, and dose dependant.

        
Physical Characteristics:      
Molecular formula: C20H29ClN2O5      
Molecular weight: 412.9      
Appearance: White or almost white, crystalline powder.      
Solubility: Freely soluble in water, soluble in acetonitrile and methanol, sparingly soluble in ethanol (96%).      
Water: Maximum 0.5%.      
Sulfated ash: Maximum 0.1%      
Purity: Minimum 99.0%.      
Assay: 97.0% to 102.0% (dried substance).      
Storage: Protected from light.      
Stability: Stable at least 2 years at R.T      
Pharmacopia:EP,BP, JP
Industrial Applications:Pharmaceutical   
category: Antitussive
Noscapine is a phthalide isoquinoline non-narcotic alkaloid derived from the opium poppy papaver somniferum with mild analgesic, anti tussive , potential antineoplastic activities. Noscapine exerts its antitussive effects through the activation of sigma opioid receptors
        
Physical Characteristics:      
Molecular formula: C22H24ClNO7,H2O      
Molecular weight: 467.9      
Appearance: White or almost white, crystalline powder or colourless crystals, hygroscopic..      
Solubility: Freely soluble in water and in ethanol (96%).  aqueous solutions are slightly acid; the base may be precipitated when the solutions are allowed to stand.      
Melting point: About 200 °C, with decomposition.      
pH : Minimum 3.0.      
Specific optical rotation: +38.5 to +44.0 (dried substance).      
Water: 2.5% to 6.5% (105 °C)      
Sulfated ash: Maximum 0.1%      
Purity: Minimum 99.0%.      
Assay: 99.0% to 101.0% (dried substance).      
Storage: In an airtight container, protected from light.      
Stability: Stable at least 2 years at R.T      
Pharmacopia:USP, BP
Industrial Applications:Pharmaceutical   
category:antispasmodic
Papaverine is an opium alkaloid antispasmodic drug., used primarily in treatment of visceral spasms and vasospasms, ocassionallyin the treatment of erectile dysfunction and acute mesenteric ischemia
        
Physical Characteristics:      
Molecular formula: C20H22ClNO4      
Molecular weight: 375.9      
Appearance: White or almost white, crystalline powder, or white or almost white crystals.      
Solubility: Sparingly soluble in water, slightly soluble in ethanol.      
Melting point: 146 – 149 °C      
pH : 3.0 – 4.5      
Water: Maximum 0.5% (105 °C)      
Sulfated ash: Maximum 0.1%      
Purity: Minimum 99.5%.      
Assay: 99.0% to 101.0% (dried substance).      
Storage: Preserve in tight, light-resistant containers. Store at 25°, excursions permitted between 15° and 30°.      
Stability: Stable at least 2 years at R.T      
Pharmacopia:In house
Industrial Applications:Pharmaceutical   
category: Antidiabetic type 2

Empagliflozin works in the kidneys to prevent absorption of glucose in order to lower the blood sugar level.it is not useful for insulin dependent or type 1 diabetes. It is used in adults with heart failure to reduce the risk of hospitalization  and death due to heart disease.itis in a class of medication called sodium-glucose co-transporter 2(SGLT2) inhibitors. 

        
Physical Characteristics:      
Molecular formula: C23H27ClO7      
Molecular weight: 450.91      
Appearance: White or off white, crystalline powder.      
Solubility: Soluble in DMSO, sparingly soluble in methanol, practically insoluble in water.      
Water: Maximum 0.5%      
Specific optical rotation: 15 to 20 .      
Heavy metals: Maximum 20 ppm.      
Residue on ignition: Maximum 0.1%      
Purity: Minimum 99.7%.      
Assay: 98.0% to 102.0% (dried substance).      
Storage: Preserve in a well-closed container. Store at controlled room temperature.      
Stability: Stable at least 2 years at R.T      
Pharmacopia:USP, BP
Industrial Applications:Pharmaceutical   
category:Antidiabetic type 2

Sitagliptine lowers blood glucose in type 2 diabetes.sitagliptine is in a class of medications called dipeptidyl peptidase-4(DPP-4) inhibitors.

        
Physical Characteristics:      
Molecular formula: C16H20F6N5O6P      
Molecular weight: 523.32      
Appearance: White or almost white powder.      
Solubility: Soluble in water, very slightly soluble in anhydrous ethanol, practically insoluble in heptane.      
Water: 3.3% to 3.7%      
Sulfated ash: Maximum 0.2%.      
Enantiomeric purity: Impurity A: Maximum 0.50%.
                                           Reporting threshold: 0.1%.		      
Purity: Minimum 99.5%.      
Assay: 98.0% to 102.0% (dried substance).      
Storage: Preserve in a well-closed container. Store at controlled room temperature.      
Stability: Stable at least 2 years at R.T      
Pharmacopia:USP
Industrial Applications:Pharmaceutical   
category: Antidiabetic type 2
Dapagliflozin is used to treat type 2 diabetes.It is used to treat adults with heart failure and chronic kidney disease.It reversibly inhibits sodium-glucose co-transporter 2 (SGLT-2)  
 in the renal proximal convoluted tubule to reduce glucose reabsorbance and inctrease urinary glucose excretion.
        
Physical Characteristics:      
Molecular formula: C21H25ClO6.C3H8O2.H2O      
Molecular weight: 502.99      
Appearance: White or off white, crystalline powder.      
Solubility: Freely soluble in methanol, soluble in acetonitrile, very slightly soluble in water.        
Water: 3.2% – 4.0%.      
Content of propanediol: 14.0%–16.5%.      
Purity: Minimum 99.7%.      
Assay: 98.0% to 102.0% on the anhydrous, propanediol-free, and solvent-free basis).      
Storage: Preserve in a well-closed container. Store at controlled room temperature.      
Stability: Stable at least 2 years at R.T      
Pharmacopia:BP
Industrial Applications:Pharmac a blood lot in the lung) in adults. Rivaroxaban is alsoeutical   
category:anticoagulant
Rivaroxaban is used to treat deep vein thrombosis (DVT: a blood clot, usually in the leg) and pulmonary embolism(PE, a blood clot in the lung) in adults.It is mainly an anticoagulantmedication used to treat and prevent blood clots.specifically it is used to treat deep vein thrombosis and pulmonary emboli and prevent atrial fibrilation and following hip or knee surgery.;
        
Physical Characteristics:      
Molecular formula: C19H18ClN3O5S      
Molecular weight: 435.88      
Appearance: White or off white, crystalline powder.      
Solubility: Soluble in DMSO, practically insoluble in ethanol.      
Water: Maximum 1.0%      
Enantiomeric purity: NLT 99.0%.      
Residue on ignition: Maximum 0.1%      
Purity: Minimum 99.5%.      
Assay: 98.0% to 102.0% (anhydrous basis).      
Storage: Preserve in tight, light-resistant containers at controlled room temperature. Keep away from heat and moisture.      
Stability: Stable at least 2 years at R.T      
Pharmacopia:BP, USP
Industrial Applications:Pharmaceutical   
category: Proton pump inhibitor

pantoprazole is used to allow the esophagus to heal and prevent further damage to the esophagus in adults with GERD.IT is also used to treat conditions where the stomach produces too much acid such as zollinger -Ellison syndrome in adults. It is used in heart burn, acid reflux and gastro intestinal reflux disease

        
Physical Characteristics:      
Molecular formula: C16H14F2N3NaO4S,1 1/2 H2O      
Molecular weight: 432.37      
Appearance: White or almost white powder.      
Solubility: Freely soluble in water and in ethanol (96%), practically insoluble in hexane.      
Water: 5.9% to 6.9%.      
Optical rotation: -0.4° to +0.4°.      
Purity: Minimum 99.5%.      
Assay: 99.0% to 101.0% (anhydrous substance).      
Storage: Protected from light.      
Stability: Stable at least 2 years at R.T      
Pharmacopia:BP, USP
Industrial Applications:Pharmaceutical   
category: Proton pump inhibitor
omeprazole is used to allow the esophagus to heal and prevent further damage to the esophagus in adults with GERD.IT is also used to treat conditions where the stomach produces too much acid such as zollinger -Ellison syndrome in adults. It is used in heart burn, acid reflux and gastro intestinal reflux disease
        
Physical Characteristics:      
Molecular formula: C17H19N3O3S      
Molecular weight: 345.42      
Appearance: White or almost white powder.      
Solubility: Very slightly soluble in water, soluble in methylene chloride, sparingly soluble in ethanol (96%) and methanol. It dissolves in dilute solutions of alkali hydroxides.      
Impurity F and G: Maximum 350 ppm for the sum of the contents.      
Water: Maximum 0.2%.      
Sulfated ash: Maximum 0.1%      
Purity: Minimum 99.5%.      
Assay: 99.0% to 101.0% (dried substance).      
Storage: In an airtight container, protected from light, at a temperature of 2°C to 8°C.      
Stability: Stable at least 2 years at R.T      
Pharmacopia:BP
Industrial Applications:Pharmaceutical   
category:Proton pump inhibitor

lansoprazole is used to allow the esophagus to heal and prevent further damage to the esophagus in adults with GERD.IT is also used to treat conditions where the stomach produces too much acid such as zollinger -Ellison syndrome in adults. It is used in heart burn, acid reflux and gastro intestinal reflux disease

        
Physical Characteristics:      
Molecular formula: C16H14F3N3O2S      
Molecular weight: 369.4      
Appearance: White or brownish powder.      
Solubility: Practically insoluble in water, soluble in anhydrous ethanol, very slightly soluble in acetonitrile.      
Water: Maximum 0.1%.      
Sulfated ash: Maximum 0.1%      
Purity: Minimum 99.4%.      
Assay: 99.0% to 101.0% (anhydrous substance).      
Storage: In an airtight container, protected from lightC.      
Stability: Stable at least 2 years at R.T      
Pharmacopia:USP, BP, JP
Industrial Applications:Pharmaceutical   
category:Antitussive

Noscapine is a phthalide isoquinoline non-narcotic alkaloid derived from the opium poppy papaver somniferum with mild analgesic, anti tussive , potential antineoplastic activities. Noscapine exerts its antitussive effects through the activation of sigma opioid receptors 
        
Physical Characteristics:      
Molecular formula: C22H23NO7      
Molecular weight: 413.43      
Appearance: White or almost white, crystalline powder or colourless crystals.      
Solubility: Freely soluble in chloroform, soluble in acetone, slightly soluble in ethanol (96%), practically insoluble in water.      
Melting point: 174 – 176 °C      
Water: Maximum 1.0%.      
Sulfated ash: Maximum 0.1%      
Optical rotation: +42° to +48°.      
Purity: Minimum 99.0%.      
Assay: 99.0% to 101.0% (anhydrous basis).      
Storage: Preserve in well-closed container.      
Stability: Stable at least 2 years at R.T