Calcium Citrate is widely used as a calcium source in pharmaceutical and nutraceutical formulations. However, pharmaceutical buyers need more than basic product information when selecting the material. They need to understand how the manufacturer controls the process, quality and finished-product specification.
Calcium Citrate manufacturing in India involves several controlled stages, from raw material selection and neutralisation to purification, washing and drying. Each stage contributes to the consistency of the finished material.
At Chemignition Laboratory, we manufacture Calcium Citrate in India and test the finished material against defined quality requirements. This article explains our general manufacturing process, important USP quality parameters and key points buyers should consider when sourcing Calcium Citrate.
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What is Calcium Citrate?
Calcium Citrate is the calcium salt of citric acid. It serves as a source of calcium in pharmaceutical, nutraceutical and other suitable formulations.
Chemignition’s Calcium Citrate has the following product characteristics:
- CAS Number: 5785-44-4
- Molecular Formula: C₁₂H₁₀Ca₃O₁₄·4H₂O
- Molecular Weight: 570.50 g/mol
- Appearance: White powder
- Grade: USP
The molecular formula represents Calcium Citrate tetrahydrate. Therefore, parameters related to water or loss on drying are important when evaluating the finished product.
Calcium Citrate Manufacturing in India
India has a well-established pharmaceutical ingredient manufacturing industry. However, buyers should evaluate a Calcium Citrate source based on the actual product specification, manufacturing controls and quality documentation rather than location alone.
At Chemignition Laboratory, the Calcium Citrate manufacturing process includes six main stages:
Raw Material Selection → Neutralisation → Purification → Filtration → Washing → Drying
These stages convert the selected raw materials into finished Calcium Citrate and help control its quality before batch release.
Calcium Citrate Manufacturing Process
The manufacture of Calcium Citrate involves reacting citric acid with a suitable calcium source. After the reaction, the product passes through purification and finishing stages before quality testing.
The exact operating parameters form part of the manufacturer’s established production process. However, the main stages can be explained as follows.
Raw Material Selection
The process starts with the selection of suitable raw materials.
We check starting materials against established requirements before using them in production. Consistent raw-material quality helps maintain the quality of the finished Calcium Citrate.
Neutralisation Reaction
Next, citric acid reacts with a suitable calcium source under controlled process conditions.
This neutralisation reaction forms Calcium Citrate. Proper process control at this stage helps achieve consistent product formation before purification.
Purification
After neutralisation, the material moves through the purification stage.
Purification helps reduce unwanted process-related materials and prepares the product for filtration and further processing.
Filtration
The filtration stage separates Calcium Citrate from the processing medium.
Effective filtration supports the subsequent washing process and helps maintain the required quality of the material.
Washing
After filtration, the material undergoes washing.
Washing helps reduce residual soluble materials remaining from the earlier processing stages. Therefore, this step contributes to the purity of the finished Calcium Citrate.
Drying
Finally, the material undergoes controlled drying.
This stage requires particular attention because Chemignition’s published USP specification includes a defined loss on drying requirement of 10.0% to 13.3%.
After drying and the required finishing operations, the material proceeds to quality-control testing.
Quality Control in Calcium Citrate Manufacturing
Quality control is an important part of Calcium Citrate manufacturing in India. Manufacturers need to confirm that the finished batch complies with its defined specification before release.
Why Manufacturing Consistency Matters
Pharmaceutical buyers do not evaluate quality based on one parameter alone. They also need consistent material from batch to batch.
For this reason, manufacturers need to control the complete process. Raw material selection affects the starting quality. Neutralisation affects product formation. Purification and washing help control unwanted materials. Finally, drying affects the finished material’s moisture characteristics.
Finished-product testing then provides data that buyers can compare against the applicable specification.
Therefore, buyers should review both the product specification and batch-specific Certificate of Analysis (COA) when evaluating Calcium Citrate.
Calcium Citrate USP Grade
Chemignition manufactures Calcium Citrate according to its published USP specification.
USP-grade material requires compliance with the applicable finished-product requirements. As a result, pharmaceutical buyers should confirm the required specification before placing an order.
The current Chemignition specification includes defined requirements for assay, loss on drying, arsenic, lead, fluoride and acid-insoluble substances.
Buyers can request the current specification and applicable quality documentation when evaluating the product for their formulation.
Applications of Calcium Citrate
Calcium Citrate has applications in pharmaceutical and nutraceutical formulations where a calcium source is required.
Pharmaceutical Applications
Pharmaceutical manufacturers use suitable Calcium Citrate grades in calcium preparations and mineral formulations.
Nutraceutical Applications
Calcium Citrate can also serve as a calcium source in dietary supplements and multimineral formulations.
Food Applications
Suitable food-grade Calcium Citrate can have applications in food and nutritional products, including calcium fortification.
However, manufacturers should select the appropriate grade according to the intended application and applicable requirements.
Calcium Citrate Packing and Storage
Suitable packing protects Calcium Citrate during handling, transportation and storage.
The material should remain in properly closed packaging and under the recommended storage conditions. Buyers purchasing commercial quantities should also confirm available pack sizes and packaging requirements before ordering.
In addition, appropriate identification and batch traceability help buyers maintain material records after receipt.
What Should Buyers Check Before Sourcing Calcium Citrate?
Before sourcing Calcium Citrate, pharmaceutical buyers should first confirm the required grade and specification.
They should then review the product specification and COA. In particular, buyers should check assay, loss on drying and applicable impurity limits.
Quality documentation, batch traceability, packaging, supply capacity and delivery requirements should also form part of the supplier-evaluation process.
This approach gives buyers a clearer picture of product suitability than selecting a source based only on price.
Calcium Citrate Manufacturing at Chemignition Laboratory
Chemignition Laboratory manufactures Calcium Citrate in India for pharmaceutical and related formulation requirements.
Our Calcium Citrate manufacturing process includes raw material selection, neutralisation, purification, filtration, washing and drying. After production, quality-control testing evaluates the finished material against its defined specification.
Chemignition also supports customers with product specifications, quality documentation, bulk packaging and domestic and international supply requirements.
For detailed technical information, buyers can review our Calcium Citrate product page or contact our team with their required grade and quantity.
Conclusion
Calcium Citrate manufacturing in India requires control across the complete production process. Raw material selection, neutralisation, purification, filtration, washing and drying all contribute to the characteristics of the finished material.
Quality testing is equally important. Parameters such as assay, loss on drying and applicable impurity limits help determine whether a batch meets its required specification.
For pharmaceutical buyers, reviewing the actual product specification and batch documentation provides a better basis for sourcing Calcium Citrate than relying only on general supplier claims.
FAQs
How is Calcium Citrate manufactured?
Manufacturers can produce Calcium Citrate by reacting citric acid with a suitable calcium source. The material then passes through purification, filtration, washing and drying before finished-product testing.
What type of Calcium Citrate does Chemignition manufacture?
Chemignition’s current product information lists Calcium Citrate with the molecular formula C₁₂H₁₀Ca₃O₁₄·4H₂O and molecular weight 570.50 g/mol.
What is the Calcium Citrate USP assay specification?
Chemignition’s currently published USP specification lists an assay requirement of 98.0% to 102.0% on the dried basis.
What is the loss on drying specification for Calcium Citrate?
Chemignition’s published USP specification lists 10.0% to 13.3% for loss on drying.
What should buyers check before purchasing Calcium Citrate?
Buyers should review the required grade, product specification, COA, assay, applicable impurity limits, packaging and relevant quality documentation before purchasing.
Does Chemignition manufacture Calcium Citrate in India?
Yes. Chemignition Laboratory manufactures Calcium Citrate in India and supports pharmaceutical and related formulation requirements.
