Sodium dihydrogen phosphate anhydrous API Manufacturers & Suppliers
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Sodium phosphate, monobasic | CAS No: 7558-80-7 | GMP-certified suppliers
A medication that treats constipation and facilitates bowel cleansing before colonoscopy by promoting intestinal water retention and stool softening for improved evacuation.
Therapeutic categories
Primary indications
- Used to treat constipation or to clean the bowel before a colonoscopy
Product Snapshot
- Sodium phosphate, monobasic is available in multiple formulation types including oral solutions, injections, suppositories, tablets, enemas, and emulsions
- It is primarily used for bowel cleansing and constipation treatment
- The product is approved for use in regulated markets, including the US and Canada
Clinical Overview
Pharmacodynamically, sodium phosphate acts by increasing fecal water content, thereby facilitating enhanced motility through the large intestine. The mechanism of action is primarily osmotic; the compound raises the solute concentration within the intestinal lumen, establishing an osmotic gradient that draws water into the lumen. This influx of water softens stool and promotes bowel evacuation, typically occurring within 30 minutes to 6 hours post administration.
Absorption of sodium phosphate is limited, with the primary pharmacological effect localized to the gastrointestinal tract. The compound undergoes minimal systemic absorption and is largely excreted unchanged. Due to its electrolyte-altering properties, sodium phosphate requires monitoring for potential disturbances in serum phosphate, sodium, and calcium levels, particularly in patients with renal impairment or fluid imbalance.
Safety considerations include the risk of electrolyte imbalances, dehydration, and rare occurrences of acute phosphate nephropathy following excessive or improper use. The drug is contraindicated in patients with pre-existing kidney disease, congestive heart failure, or electrolyte abnormalities. Close attention to dosing and patient hydration status is necessary to minimize adverse effects.
Sodium phosphate, monobasic, is included in multiple drug categories such as laxatives, electrolyte solutions, and pharmacy additives for intravenous solutions. It is recognized for its utility in medical procedures requiring bowel cleansing and in the management of constipation.
For API procurement, quality considerations must include compliance with pharmacopeial standards for purity, particle size, and impurity profile. The inorganic nature and critical electrolyte content mandate stringent control of manufacturing processes to prevent contamination and ensure batch uniformity, supporting safe clinical use across diverse patient populations.
Identification & chemistry
| Generic name | Sodium phosphate, monobasic |
|---|---|
| Molecule type | Small molecule |
| CAS | 7558-80-7 |
| UNII | KH7I04HPUU |
| DrugBank ID | DB09449 |
Pharmacology
| Summary | Sodium phosphate acts as an osmotic laxative by increasing solute concentration in the intestinal lumen, which enhances water retention through osmotic gradients. This increase in fecal water content facilitates bowel motility and evacuation. It is primarily used for bowel cleansing and relief of constipation. |
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| Mechanism of action | Sodium phosphate is thought to work by increasing the amount of solute present in the intestinal lumen thereby creating an osmotic gradient which draws water into the lumen . |
| Pharmacodynamics | Sodium phosphate inceases fecal water content to increase mobility through the large intestine . |
ADME / PK
| Absorption | Tmax for phosphate absorption with orally administered liquid sodium phosphate is 1-3h . |
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Formulation & handling
- Sodium phosphate monobasic is primarily formulated for intravenous and oral administration, with additional routes including rectal and intrathecal.
- As a small inorganic molecule, it does not exhibit peptide or biologic sensitivity but requires careful handling to maintain solution stability.
- Formulations may include solutions, emulsions, and tablets, indicating compatibility across diverse delivery systems and the need for appropriate storage conditions to prevent degradation.
Regulatory status
| Lifecycle | The active pharmaceutical ingredient is marketed in the US and Canada, with primary patent protection in the United States expiring in June 2028, indicating continued lifecycle maturity primarily in the US market. Previous patent protections in the US have already expired. |
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| Markets | US, Canada |
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Supply Chain
| Supply chain summary | The supply landscape for sodium phosphate, monobasic includes multiple originator companies holding patents primarily in the United States, with notable patent expirations occurring in 2021 and 2028. Branded products are predominantly present in the US and Canadian markets. The recent patent expiration in 2021 indicates the potential for existing generic competition, while the later expiration in 2028 may delay further generic entry for certain formulations. |
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Safety
| Toxicity | Intamuscular LD50 of 250mg/kg and oral LD50 of 8290 mg/kg reported in rats . Phosphate toxicity is likely due to the disturbance of other electrolytes when phosphate levels are high, producing symptoms including tetany, dehydration, hypotension, tachycardia, hyperpyrexia, cardiac arrest and coma . Risk of raising phosphate levels through use of sodium phosphate appears to be higher in smaller patients . |
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- Intramuscular LD50 in rats is 250 mg/kg
- Oral LD50 is 8290 mg/kg, indicating moderate systemic toxicity via parenteral exposure
- Elevated phosphate concentrations can disrupt electrolyte balance, potentially causing tetany, dehydration, hypotension, tachycardia, hyperpyrexia, cardiac arrest, and coma
Sodium dihydrogen phosphate anhydrous is a type of Calcium regulators
Calcium regulators are a vital subcategory of pharmaceutical Active Pharmaceutical Ingredients (APIs) used in the field of medicine. These compounds play a crucial role in maintaining the balance of calcium levels within the body. Calcium is an essential mineral that participates in numerous physiological processes, including muscle contraction, nerve transmission, and bone health.
Pharmaceutical APIs classified as calcium regulators are designed to modulate the levels of calcium in the body, either by increasing or decreasing its concentration as needed. These APIs act by targeting specific mechanisms involved in calcium regulation, such as calcium channels, transporters, or enzymes.
Calcium regulators find application in the treatment of various medical conditions. For instance, drugs that promote calcium absorption or enhance bone mineral density can be employed to manage osteoporosis, a condition characterized by weak and brittle bones. Conversely, medications that inhibit calcium channels or reduce calcium levels are used in the treatment of conditions like hypertension or cardiac arrhythmias.
The development of calcium regulators involves extensive research and rigorous testing to ensure their safety and efficacy. Pharmaceutical companies invest significant resources in the discovery, synthesis, and optimization of these APIs. Additionally, regulatory authorities closely monitor the production and distribution of calcium regulators to ensure compliance with stringent quality standards.
In summary, calcium regulators are a specialized category of pharmaceutical APIs that play a crucial role in maintaining calcium balance within the body. These compounds are integral to the treatment of various medical conditions and require rigorous research and testing to ensure their effectiveness and safety.
Sodium dihydrogen phosphate anhydrous (Calcium regulators), classified under Metabolic Bone Disease Agents
Metabolic Bone Disease Agents are a category of pharmaceutical active pharmaceutical ingredients (APIs) that are specifically designed to treat and manage conditions related to the bones and their metabolism. These agents play a crucial role in the treatment of various metabolic bone diseases, including osteoporosis, Paget's disease, and rickets.
The primary function of Metabolic Bone Disease Agents is to regulate bone remodeling and maintain bone health. They achieve this by targeting specific pathways involved in bone metabolism, such as osteoclast and osteoblast activity, calcium regulation, and vitamin D metabolism.
These APIs are commonly used in the development of medications, including oral tablets, injectables, and topical formulations, for the effective treatment of metabolic bone diseases. They are carefully formulated to optimize their pharmacokinetic and pharmacodynamic properties, ensuring maximum efficacy and minimal side effects.
Metabolic Bone Disease Agents encompass a range of substances, including bisphosphonates, selective estrogen receptor modulators (SERMs), calcitonin, and vitamin D analogs. These APIs act through different mechanisms to address specific aspects of bone health, such as inhibiting bone resorption, promoting bone formation, or regulating calcium levels.
In conclusion, Metabolic Bone Disease Agents are a vital category of pharmaceutical APIs used in the development of medications for the treatment and management of various metabolic bone diseases. These agents target specific pathways involved in bone metabolism to regulate bone remodeling, enhance bone health, and alleviate the symptoms associated with these conditions.
Sodium dihydrogen phosphate anhydrous API manufacturers & distributors
Compare qualified Sodium dihydrogen phosphate anhydrous API suppliers worldwide. We currently have 5 companies offering Sodium dihydrogen phosphate anhydrous API, with manufacturing taking place in 5 different countries. Use the table below to review supplier type, countries of origin, certifications, product portfolio and GMP audit availability.
| Supplier | Type | Country | Product origin | Certifications | Portfolio |
|---|---|---|---|---|---|
| Blue Eyes Biotech Co., Lt... | Producer | United Kingdom | United Kingdom | CoA | 35 products |
| DNS Fine Chemicals | Producer | India | India | CoA | 8 products |
| Duchefa Farma B.V. | Distributor | Netherlands | Germany | CoA, GMP, ISO9001, MSDS | 170 products |
| Fujifilm Wako Pure Chemic... | Producer | Japan | Japan | BSE/TSE, CoA, ISO9001, MSDS | 55 products |
| Jost Chemical | Producer | United States | United States | CoA, USDMF | 14 products |
When sending a request, specify which Sodium dihydrogen phosphate anhydrous API quality you need: for example EP (Ph. Eur.), USP, JP, BP, or another pharmacopoeial standard, as well as the required grade (base, salt, micronised, specific purity, etc.).
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