Cromolyn Sodium Powder

Premium Cromolyn Sodium Powder for Pharmaceutical Applications – High-Purity API with Full Quality Assurance

​​​​​​​Shaanxi Hongda Phytochemistry Co., Ltd. cromolyn Sodium Powder is a major producer and supplier of high purity product, providing the world with active medicinal ingredients. We have more than 20 years of experience since 2001, with a 20,000 square metre plant, including 100,000 level purification workshops and advanced manufacturing lines, with an annual capacity of 3,000 tonnes. Our product conforms to worldwide pharmacopeial standards of more than 99% purity and is supported by Certifications such as HALAL, KOSHER, cGMP, FSSC22000, ISO9001, and ISO22000. For your formulation requirements we have stringent quality control systems, laboratory testing standardised by SGS, and a professor-level R&D staff that guarantees every batch is consistent with pharmaceutical excellence.

Product Introduction

The product is a pharmaceutical grade mast cell stabiliser formulated to limit the release of inflammatory mediators in allergic situations. The white crystalline powder is highly soluble in aqueous solutions . It is chemically stable at neutral pH . The chemical acts prophylactically to block histamine and leukotriene degranulation from mast cells, providing a steroid sparing treatment alternative for chronic respiratory and allergy illnesses. Our product meets the standard criteria of USP, EP and BP for consistent performance in inhalation formulations, ophthalmic solutions and oral concentrate applications.

Third Party Testing Report

Microbiological Safety: Total plate count is less than 1000 CFU/g, yeast and mould is less than 100 CFU/g and Salmonella and E. coli are negative as tested by independent SGS and Eurofins, satisfying pharmaceutical microbiological criteria.

Heavy Metal Analysis: Complete screening of heavy metals showed lead level less than 1 ppm, arsenic less than 0.5 ppm, mercury less than detection limits and cadmium less than 0.3 ppm which is entirely consistent with the ICH Q3D elemental impurity recommendations.

Pesticide Residue Verification: Multi-residue analysis of 500+ chemicals meets clean label pharmaceutical production criteria with no detected pesticide contamination.

Cromolyn Sodium Powder Advantages

Pharmaceutical Purity: Our controlled crystallisation and multi-stage purification provide reproducible bioavailability in final dosage forms at 99%+ purity.

Humidity-controlled processing Special production desiccation technologies prevent hygroscopic moisture absorption, extending shelf life to 36 months with optimal storage conditions and retaining powder flowability for automated filling equipment.

Complete paperwork: Every batch is accompanied by comprehensive regulatory support paperwork including DMFs (Drug Master Files), CoAs with batch traceability, stability data, and residual solvent analysis to fast-track your regulatory submission timeframes.

Global Compliance: We are cGMP compliant on an ongoing basis with frequent audits at our plant, ensuring supply chain integrity for FDA, EMA and PMDA regulated markets.

Use of Cromolyn Sodium Powder

Respiratory Therapeutics: Metered-dose inhalers and nebulisers for asthma prevention, particularly in children who require non-steroidal long-term management.

Mast cell stabilisation in sterile eye drops for allergic conjunctivitis removes seasonal allergy symptoms without systemic corticosteroid exposure.

Mast cell diseases – Used in oral concentrate formulations to treat gastrointestinal symptoms of mast cell disorders, providing focused relief with little systemic absorption.

Allergic Rhinitis Solutions: Developed as nasal spray formulations offering prophylactic protection against environmental allergens via localised mast stabilisation in nasal mucosa.

Manufacturing Process

Step 1 – Selection of Raw Materials: The precursors of pharmaceutical grade are thoroughly tested for their identification by FTIR and NMR spectroscopy to ensure chemical purity before the start of synthesis.

Step 2 – Controlled Synthesis: Under strict temperature and pH control, multi-stage chemical reactions are carried out to provide the bis-chromone structure with optimum yield and minimum production of impurities.

Step 3 – Crystallisation Purification: Controlled cooling, solvent exchange methods provide consistent crystal morphology, target particle size distribution for improved dissolving properties.

Step 4 – Desiccation and Milling Vacuum-drying under inert atmosphere to eliminate residual solvents to <50 ppm, followed by cryogenic milling to produce free-flowing powder fulfilling 80-mesh requirements.

Step 5 - Quality Verification: Before permission for release, each manufacturing batch undergoes stringent testing using HPLC purity analysis, residual solvent screening, heavy metal measurement and microbiological challenge testing.

Why Choose Us

Shaanxi Hongda Phytochemistry has 23 years of manufacturing expertise and top-notch analytical ability. Pharmaceutical grade quality guaranteed by SGS-standardized laboratory with HPLC, GC-MS and ICP-MS apparatus. We have a 3,000 square metre warehouse that holds key goods for 3-7 day delivery windows, so you have supply chain stability. Our certifications like HALAL, KOSHER, ORGANIC (EU/NOP) and cGMP are our promise to the worldwide quality standards. With more than 150 qualified specialists and a comprehensive quality control system, we can guarantee a steady supply of pharmaceutical raw materials to support your product success in European, North American and Asian markets.

OEM / ODM assistance

Development of Custom Formulas Our 20+ PhD-level experts create unique formulations, changing Cromolyn Sodium Powder to 0.5% to 4% based on your therapeutic goal and delivery strategy.

Custom Packaging: We provide 100g aluminium foil packets for lab samples and 25kg fibre drums for commercial quantities. We protect your valuables using moisture-barrier and desiccant technologies.

Regulatory Assistance Our documentation professionals provide technical dossiers such as description of manufacturing process, analytical technique validation reports and stability studies to assist your IND, ANDA or NDA filing.

Scalable Production Pilot batch capabilities from 50kg to full scale production runs provide easy technology transfer with dedicated production campaigns ensuring batch to batch consistency until commercialisation.

Our Certifications

Our Exhibitions

FAQ

Q: How to keep the product to avoid degradation?

A: Store in cold, dry settings below 25°C in sealed containers with desiccants. Once opened, minimise air exposure and reseal promptly to reduce moisture absorption which will negatively impact flowability.

Q: How long is the lead time for bulk orders?

A: We send standard manufacturing batches within 3-7 business days. Speciality packaging or custom synthesis may take 10-15 working days depending on requirements.

Q: Can you provide samples for formulation development?

A：Yes, we supply 100-500g development samples with full CoA documentation. Contact our team to discuss your specific testing requirements.

Q: Is your product suitable for sterile formulations?

A：Our pharmaceutical-grade powder meets USP microbial limits. For sterile applications, we recommend secondary sterilization or aseptic processing with appropriate bioburden reduction steps.

Q: What documentation supports regulatory filings?

A：We provide comprehensive DMF references, multi-batch CoAs, stability studies (up to 36 months), residual solvent analysis, and elemental impurity reports compliant with ICH guidelines.

Contact Us

Ready to secure pharmaceutical-grade Cromolyn Sodium Powder for your next formulation? Contact Us today at duke@hongdaherb.com  to request samples, discuss specifications, or explore OEM/ODM collaboration opportunities.