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Suppliers and packagers for POTASSIUM PHOSPHATES
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POTASSIUM PHOSPHATES
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Am Regent | POTASSIUM PHOSPHATES | potassium phosphate, dibasic; potassium phosphate, monobasic | SOLUTION;INTRAVENOUS | 216274 | ANDA | American Regent, Inc. | 0517-2051-25 | 25 VIAL, SINGLE-DOSE in 1 TRAY (0517-2051-25) / 5 mL in 1 VIAL, SINGLE-DOSE (0517-2051-01) | 2023-10-13 |
| Am Regent | POTASSIUM PHOSPHATES | potassium phosphate, dibasic; potassium phosphate, monobasic | SOLUTION;INTRAVENOUS | 216274 | ANDA | American Regent, Inc. | 0517-2102-25 | 25 VIAL, SINGLE-DOSE in 1 TRAY (0517-2102-25) / 15 mL in 1 VIAL, SINGLE-DOSE (0517-2102-01) | 2023-10-13 |
| Am Regent | POTASSIUM PHOSPHATES | potassium phosphate, dibasic; potassium phosphate, monobasic | SOLUTION;INTRAVENOUS | 216274 | ANDA | American Regent, Inc. | 0517-2505-25 | 25 VIAL, PHARMACY BULK PACKAGE in 1 TRAY (0517-2505-25) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE (0517-2505-01) | 2023-10-13 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers and packagers for POTASSIUM PHOSPHATES
Suppliers for Potassium Phosphates (Food, Pharma, and Technical Grades): Which Companies Provide APIs and Pharmaceutical-Use Materials?
Executive summary
Potassium phosphates used in pharmaceutical settings are typically supplied as either (1) single salts such as dipotassium hydrogen phosphate (K2HPO4), monopotassium phosphate (KH2PO4), and potassium phosphate dibasic products, or (2) buffered phosphate systems prepared for formulation use. The supply base is concentrated among global inorganic chemical manufacturers and specialty excipient/pharma-grade suppliers, with most market-ready materials sold under multiple pharmacopeial standards (USP/NF, EP, BP) and common particle/assay specifications.
Because the term “potassium phosphates” spans multiple chemical forms, the supplier landscape depends on the specific salt form and grade (USP/EP vs. technical), but the major supplier categories and repeat-appearing global sources are consistent.
Who are the main suppliers of potassium phosphate salts used in pharmaceuticals?
Featured snippet answer: The primary suppliers of pharmaceutical-grade potassium phosphate salts are large inorganic chemical manufacturers and pharma-excipient distributors, with frequent global sources including Merck (MilliporeSigma), Thermo Fisher Scientific (via inorganic reagent lines), BASF, AkzoNobel/industrial phosphate portfolio entities, and excipient distributors carrying USP/EP-compliant phosphate salts, alongside regional inorganic chemical producers.
Common potassium phosphate forms and what suppliers typically offer
Most pharmaceutical purchases break down by the specific salt:
- Monopotassium phosphate (KH2PO4)
- Dipotassium hydrogen phosphate (K2HPO4)
- Potassium phosphate dibasic / phosphate buffer components
- Mixed potassium phosphate buffers (prepared blends for formulation)
In practice, buyers source either:
- the single-salt API/excipient, then formulate buffers in-house; or
- pre-specified buffering systems sold to meet formulation and stability requirements.
Which companies supply USP/EP potassium phosphate excipients and reagents?
Featured snippet answer: Global reagent and excipient channels commonly provide USP/EP potassium phosphate salts through branded inorganic reagent lines and pharma-grade distributor listings.
Reagent and life-science suppliers that typically carry potassium phosphate salts
These companies frequently list potassium phosphate salts in commerce under pharmacopeial or analytical specifications:
- Merck KGaA / MilliporeSigma (broad inorganic reagent catalog; includes potassium phosphate salts in multiple grades)
- Thermo Fisher Scientific (inorganic salts catalog through branded reagents and lab supply channels)
- Fisher Scientific / VWR distribution networks (often as reseller channels for USP-grade inorganic salts)
Excipient and specialty chemical suppliers that frequently list potassium phosphate salts
- BASF (inorganic chemicals supply; many phosphate-related chemicals are sold into pharma and chemical production channels depending on grade)
- Acros Organics / industrial chemistry channels via global distributors (often relevant for research-grade, sometimes pharma grade depending on contract)
Distribution and contract packaging
For pharma use, buyers often select suppliers through distributor listings because:
- CoA and compliance packages are standardized
- Packaging sizes align with manufacturing and quality workflows
- Lead-time and batch documentation are contract-managed
What pharmaceutical-grade potassium phosphate salts are sold, and which supplier types cover each?
Featured snippet answer: Pharmaceutical-grade sourcing typically splits between large inorganic chemical manufacturers for bulk supply and life-science/excipient channels for controlled pharmacopeial specs and smaller pack sizes.
Typical procurement split by grade
- USP/NF or EP-compliant: excipient suppliers, pharma reagent suppliers, and contracted inorganic manufacturers with regulated documentation
- Analytical grade: life-science reagent channels (MilliporeSigma, Thermo Fisher)
- Technical grade: bulk inorganic manufacturers for non-pharma internal use or lower-compliance applications
Which salt forms require higher spec control in pharma
- Dipotassium hydrogen phosphate (K2HPO4): common buffer component; spec typically tight on assay, pH suitability, and impurities
- Monopotassium phosphate (KH2PO4): used for buffering and as pH adjuster salts; impurities (e.g., heavy metals, sulfate, chlorides) are controlled
- Mixtures/buffer blends: spec control extends to pH range, conductivity, and microbial/bioburden where applicable
What are the key supplier qualification requirements for potassium phosphate in pharma?
Featured snippet answer: Pharma buyers typically qualify based on pharmacopeial compliance, impurity profiles, traceability and batch-to-batch consistency, and quality documentation.
Documents and data that drive supplier selection
- CoA aligned to USP/NF or EP monograph
- Impurity report (heavy metals, sulfate, chloride, calcium/magnesium levels depending on monograph)
- Elemental analysis and control strategy
- DMF/ASMF references where relevant to a manufacturer’s quality system (less common for simple inorganic salts but may exist for specific grades)
- GMP status: supplier facility manufacturing/quality system documentation
- Stability and compatibility data when used in finished dosage buffers (rare for the salt itself, more common at formulation level)
How does the supplier landscape differ by region (US, EU, China, India)?
Featured snippet answer: In the US and EU, potassium phosphate supply is typically served by large inorganic chemical producers plus pharma-grade distributors. In China and India, the bulk supply chain often dominates upstream production, then compliance grades are distributed into regulated markets.
US and EU sourcing pattern
- Buyers leverage local distribution for lead time
- Multiple supplier options exist for USP/EP-compliant formats
- Packaging and documentation are standardized through distributor agreements
Asia sourcing pattern
- Bulk inorganic production is concentrated
- Pharma compliance grades enter through contract packaging and distributor relabeling into regulated markets
- Qualification is heavily documentation-driven
Which companies are most visible for bulk potassium phosphate supply to chemical manufacturers?
Featured snippet answer: Visibility in bulk inorganic chemical procurement often points to large global inorganic chemical manufacturers with broad phosphate portfolios, sold through industrial chemical divisions and contract supply.
Supplier type mapping
- Global inorganic manufacturers: bulk chemistry supply and multi-commodity phosphate products
- Specialty inorganic chemical producers: phosphate salts with controlled impurity profiles for higher-spec downstream use
- Pharma reagent and excipient channels: same or equivalent base salts, packaged and documented for regulated quality systems
How does potassium phosphate supplier choice affect manufacturing and formulation risk?
Featured snippet answer: Variability risk comes from differences in impurity profile, moisture/hydrate behavior, and particle size distribution that impact buffer performance, pH stability, and filterability.
Risk points for formulation and process
- Impurity-driven pH drift or ionic strength mismatch in buffers
- Moisture uptake affecting weighing accuracy and solid-state handling
- Particle size distribution affecting dissolution rate and blend uniformity
- Trace metals potentially impacting oxidative degradation pathways in sensitive formulations
- Supply interruption risk due to phosphate concentration tied to upstream availability and reactor/plant operations
What generic or finished drug manufacturers typically buy potassium phosphates from which supplier channels?
Featured snippet answer: Finished-dose manufacturers typically buy potassium phosphate salts from GMP-excipient or reagent channels with robust CoA workflows, rather than directly from technical-grade industrial sources.
Procurement channels by use
- Buffering excipient use: GMP-excipient channels and contracted inorganic suppliers
- pH adjustment: life-science/reagent channels or GMP bulk suppliers, depending on regulatory setting
- Lab and analytics: analytical grade from major life-science distributors
Key Takeaways
- “Potassium phosphates” in pharma generally means specific phosphate salts used as buffers and pH adjusters, most commonly KH2PO4 and K2HPO4.
- Supplier coverage is split between large inorganic chemical manufacturers (bulk production) and pharma-grade excipient/reagent distributors (regulated documentation and packaging).
- Supplier selection is driven by USP/NF or EP compliance, impurity profiles, batch traceability, and buffer performance consistency.
- Formulation risk is tied to impurities, moisture behavior, and particle size rather than the basic chemical identity alone.
FAQs
1) Are potassium phosphate salts considered excipients in US drug products?
Yes, commonly used as buffering agents and pH adjusters in many formulations and therefore handled as excipients (with pharmacopeial compliance expectations).
2) What is the difference between monopotassium phosphate and dipotassium hydrogen phosphate for formulations?
KH2PO4 and K2HPO4 differ in their buffering capacity and pH characteristics based on their acid-base pair behavior, which affects buffer pH selection and ionic strength.
3) Do pharma suppliers sell potassium phosphate as USP/NF and EP grades?
Often yes, via excipient and pharma reagent channels that provide monograph-aligned documentation and consistent impurity controls.
4) What impurity parameters matter most for potassium phosphate in pharma quality review?
Typical focus includes heavy metals and regulated inorganic impurity limits such as sulfate, chloride, and related cations depending on the applicable monograph.
5) Can the same supplier provide multiple potassium phosphate salts for a buffer system?
In practice, yes. Many suppliers and distributor networks carry both KH2PO4 and K2HPO4, enabling matched sourcing for buffer components.
References
- United States Pharmacopeia and National Formulary (USP–NF). Relevant monographs for potassium phosphate salts (current editions).
- European Pharmacopoeia (Ph. Eur.). Relevant monographs for potassium phosphate salts (current editions).
- Merck KGaA (MilliporeSigma). Product catalogs for potassium phosphate salts.
- Thermo Fisher Scientific. Product catalogs for potassium phosphate salts and inorganic reagent listings.
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