Folinic Acid Calcium salt 1492-18-8 Manufacturer Supplier Exporter MEDIOCON INC

 

 

 

Folinic Acid Calcium salt Manufactured by MEDIOCON INC

 

   Name: Folinic Acid Calcium salt

CAS No:   1492-18-8

Molecular Weight:  511.50 g/mol

Molecular formula:   C₂₀H₂₁CaN₇O₇

Synonyms: Folinic acid calcium salt hydrate.

Appearance:  Pale Yellow Solid.

 Solubility : Solubility, 0.92g/ml in water, practically insoluble in Ethanol.

Use :

Folinic acid calcium salt, also known as leucovorin calcium, has several uses:

 

1. Cancer treatment: It's used to reduce side effects of certain chemotherapy drugs, like methotrexate.

2. Folate deficiency: Treats folate deficiency anemia.

3. Overdose treatment: Helps counteract overdose of methotrexate or other folate antagonists.

 How is Folinic Acid Calcium salt manufactured by MEDIOCON INC Synthesized?

Folinic acid calcium salt is synthesized through a multi-step process:

 

1. Starting material: Typically begins with folic acid.

2. Reduction: Folic acid is reduced to form dihydrofolate.

3. Formylation: Dihydrofolate is then formylated to produce folinic acid.

4. Salt formation: Folinic acid is then combined with calcium to form the calcium salt.

 

What are the different  dosage forms  of  Folinic Acid Calcium salt Manufactured  by  MEDIOCON INC?

Folinic acid calcium salt is available in various dosage forms, including:

- Tablets: 15mg tablets are commonly used for oral administration.

- Capsules: 5mg and 25mg capsules are also available for oral use.

- Injectable solutions: Vials containing 50mg per 5ml, 100mg per 10ml, and 300mg per 30ml are used for intravenous administration. Some formulations may require reconstitution with sterile water for injection.

- Powder for injection: A 350mg powder formulation is available for emergency use, which must be reconstituted with 17.5ml sterile water for injection.

 

These dosage forms cater to different patient needs and administration routes. The specific dosage and form used may depend on the condition being treated, such as preventing hematological toxicity caused by pyrimethamine or managing methotrexate toxicity.

 How Folinic Acid Calcium salt Manufactured by MEDIOCON INC   Dosage Forms are prepared?

The preparation of Folinic acid calcium salt dosage forms involves various steps depending on the dosage form:

 

Tablets:

 

1. Mixing of active ingredient (Folinic acid calcium salt) with excipients.

2. Granulation (wet or dry) to improve flow and compression properties.

3. Compression into tablets.

 

Capsules:

 

1. Filling of capsules with Folinic acid calcium salt powder.

2. Addition of excipients (e.g., fillers, lubricants).

3. Capsule sealing.

 

Injectable solutions:

1. Weighing and dissolving Folinic acid calcium salt in a suitable solvent.

2. Adding pH adjusters and stabilizers.

3. Filtration and filling into vials or ampoules.

4. Sterilization (autoclaving or aseptic filtration).

Lyophilized powder for injection:

1. Dissolving Folinic acid calcium salt in a suitable solvent.

2. Filtration and filling into vials.

3. Lyophilization (freeze-drying) to remove water.

The specific preparation method may vary depending on the manufacturer and regulatory requirements.

What are the appropriate Dosage forms of Folinic Acid Calcium salt Manufactured  by  MEDIOCON   INC?                

The appropriate dosage forms of Folinic acid calcium salt depend on the specific indication and patient needs. Common dosage forms include:

1. Oral tablets or capsules: For folate deficiency, anemia, or as a supplement.

2. Injectable solutions: For intravenous or intramuscular administration, often used in:

    1. Cancer treatment (e.g., methotrexate rescue).

    2. Emergency treatment of folate antagonist overdose.

    3. Certain cases of anemia or folate deficiency.

The choice of dosage form and route of administration depends on the patient's condition, medical history, and treatment goals. Consult a healthcare professional for personalized guidance

When should Folinic Acid Calcium salt Manufactured by MEDIOCON INC be taken?

Folinic acid calcium salt can be taken:

 

1. As directed by a healthcare provider.

2. At the same time each day to maintain consistent levels.

3. With or without food, depending on the formulation and patient tolerance.

For specific timing, follow these general guidelines:

1. Methotrexate rescue: Typically started 24 hours after methotrexate administration.

2. Folate deficiency: Usually taken once daily.

3. Other conditions: Follow the healthcare provider's instructions.

Adhere to the prescribed dosage and schedule to ensure effectiveness and minimize potential side effects. Consult a healthcare provider for personalized guidance.

 What are the effects And Side effects of Folinic Acid Calcium salt Manufactured by MEDIOCON INC?

Effects of Folinic Acid Calcium Salt:

 

1. Folate supplementation: Treats folate deficiency and related anemia.

2. Methotrexate rescue: Counteracts methotrexate toxicity.

3. Supports cellular function: Essential for DNA synthesis and repair.

 

Side Effects:

 

1. Allergic reactions: Rare, but possible (rash, itching, swelling).

2. Gastrointestinal issues: Nausea, vomiting, diarrhea (rare).

3. Hypersensitivity: Anaphylaxis (rare).

 

Serious Side Effects (rare):

 

1. Seizures: High doses may increase seizure risk.

2. Allergic reactions: Severe reactions require immediate medical attention.

 

Interactions:

 

1. Anticonvulsants: May decrease folinic acid levels.

2. Chemotherapy: May interfere with efficacy (consult healthcare provider).

Precautions:

1. Pregnancy and breastfeeding: Consult healthcare provider.

2. Folate-dependent tumors: Use with caution.

Consult a healthcare provider for personalized guidance and monitoring.

  How is Folinic Acid Calcium salt Manufactured by MEDIOCON  INC  Tested Qualitatively?

Qualitative testing of Folinic Acid Calcium salt involves various analytical techniques to identify and confirm its presence and characteristics. Some methods include:

 

1. High-Performance Liquid Chromatography (HPLC): Separates and detects components based on chemical properties.

2. Infrared Spectroscopy (IR): Identifies functional groups through molecular vibrations.

3. Ultraviolet-Visible Spectroscopy (UV-Vis): Measures absorbance and detects chromophores.

4. Mass Spectrometry (MS): Determines molecular weight and structure.

5. Thin-Layer Chromatography (TLC): Separates components based on adsorption properties.

   Which tests are performed on Folinic Acid Calcium salt Manufactured by  MEDIOCON INC ?

Folinic Acid Calcium salt undergoes various tests to ensure its quality, purity, and potency. Some common tests include:

 

Physical Tests:

 

1. Appearance: Visual inspection for color, texture, and consistency.

2. Solubility: Testing solubility in water and other solvents.

 

Chemical Tests:

 

1. Identification: IR, UV-Vis, or HPLC to confirm identity.

2. Purity: HPLC or TLC to detect impurities.

3. Assay: Quantitative analysis to determine potency.

4. pH: Measurement of pH in solution.

Microbial Tests:

1. Sterility: Ensures absence of microorganisms (for injectable forms).

2. Endotoxin testing: Detects bacterial endotoxins.

Other Tests:

1. Heavy metals: Testing for heavy metal impurities.

2. Related substances: Detection of related compounds or impurities.

What are the challenges in Manufacturing of Folinic Acid Calcium salt Manufactured by MEDIOCON   INC API?

The manufacturing of Folinic Acid Calcium salt API (Active Pharmaceutical Ingredient) poses several challenges, including:

 

Chemical Challenges:

 

1. Complex synthesis: Multi-step synthesis process requires precise control.

2. Impurity control: Managing impurities and by-products is crucial.

 

Regulatory Challenges:

 

1. Compliance with GMP: Adhering to Good Manufacturing Practices ensures quality.

2. Regulatory approvals: Meeting requirements from regulatory agencies.

 

Quality Control Challenges:

 

1. Purity and potency: Ensuring consistent quality and potency.

2. Stability: Maintaining stability during manufacturing, storage, and transportation.

Supply Chain Challenges:

1. Raw material sourcing: Ensuring quality and availability of raw materials.

2. Supply chain management: Managing logistics and distribution.

Technical Challenges:

1. Process optimization: Optimizing manufacturing processes for efficiency and yield.

2. Scale-up: Scaling up production while maintaining quality.

These challenges require expertise, investment, and strict quality control measures to ensure the production of high-quality Folinic Acid Calcium salt API.

What are the challenges in manufacturing of Folinic Acid Calcium salt Manufactured by MEDIOCON  INC ’s Dosage forms?

The manufacturing of Folinic Acid Calcium salt dosage forms poses several challenges, including:

 

Formulation Challenges:

 

1. Stability issues: Ensuring chemical stability during manufacturing, storage, and transportation.

2. Compatibility: Ensuring compatibility with excipients and packaging materials.

 

Manufacturing Challenges:

 

1. Uniformity: Achieving uniform content and blend uniformity.

2. Process control: Controlling parameters like temperature, humidity, and pressure.

 

Regulatory Challenges:

 

1. Compliance with GMP: Adhering to Good Manufacturing Practices.

2. Regulatory approvals: Meeting requirements from regulatory agencies.

 

Quality Control Challenges:

 

1. Impurity profiling: Detecting and controlling impurities.

2. Assay and content uniformity: Ensuring accurate potency and uniformity.

Packaging and Storage Challenges:

1. Light and moisture protection: Protecting the product from degradation.

2. Packaging material compatibility: Ensuring compatibility with packaging materials.

Other Challenges:

1. Cost control: Managing production costs while maintaining quality.

2. Supply chain management: Ensuring timely delivery of raw materials and finished products.

These challenges require careful planning, expertise, and investment in manufacturing processes and quality control systems.

What is the Packing for Folinic Acid Calcium salt Manufactured by MEDIOCON INC?

Folinic Acid Calcium salt packaging typically includes:

Primary Packaging:

1. Vials: Glass or plastic vials for injectable forms.

2. Tablets/Capsules: Blister packs, bottles, or strips.

Secondary Packaging:

1. Cartons: Paperboard cartons for individual units or multipacks.

2. Labels: Labels with product information, instructions, and warnings.

Protective Packaging:

1. Light protection: Amber or dark-colored containers to protect from light.

2. Moisture protection: Desiccants or moisture-absorbing materials.

Labeling:

1. Product name: Folinic Acid Calcium salt.

2. Strength: Dosage strength (e.g., 15mg, 50mg).

3. Instructions: Administration instructions and warnings.

Packaging may vary depending on the manufacturer, dosage form, and regulatory requirements.

What is shelf life Of Folinic Acid Calcium salt Manufactured by MEDIOCON INC? 

The shelf life of Folinic Acid Calcium salt depends on the storage conditions. Here are some general guidelines¹:

- Powder:

    - 3 years at -20°C

    - 2 years at 4°C

- In solvent:

    - 6 months at -80°C

    - 1 month at -20°C

 

It's essential to keep the container tightly sealed in a cool, well-ventilated area, away from direct sunlight and sources of ignition. The recommended storage temperature for the powder is -20°C for up to 3 years. Always check the product label or manufacturer's instructions for specific storage recommendations and expiration dates.

What should the label claim for Folinic Acid Calcium salt Manufactured by MEDIOCON INC   Include?

The label claim for Folinic Acid Calcium salt should include:

 

1. Product Name: Folinic Acid Calcium salt

2. Strength: Amount of folinic acid per unit (e.g., 15mg, 50mg)

3. Dosage Form: (e.g., tablets, capsules, injectable solution)

4. Route of Administration: (e.g., oral, intravenous, intramuscular)

5. Storage Conditions: (e.g., room temperature, refrigerate, protect from light)

6. Expiration Date: Date after which the product should not be used

7. Batch Number: Unique identifier for the batch

8. Manufacturer's Name and Address: Information about the manufacturer

9. Directions for Use: Instructions for administration

10. Warning/Precautions: Any relevant warnings or precautions

Where can Folinic Acid Calcium salt Manufactured by MEDIOCON INC are procured?

Folinic Acid Calcium Salt Manufactured by MEDIOCON INC   can be procured from various sources, depending on your location and requirements. Here are some options:

FOR API

MEDIOCON INC

Add: B-2, ARCH SARTHAK BUILDING, N-7 CIDCO

CHATRAPATI SAMBHAJI NAGAR-431003, MAHARASHTRA, INDIA

Mob/WhatsApp No: +91-8007719681, +91-9309999757, +91-9834786939

Sales Department: Email: sales@mediocon.com

Purchase Department: Email: purchase@mediocon.com

Marketing Department: Email: mktg@mediocon.com

HR Department: Email: hr@mediocon.com

Accounts Department: Email: accounts@mediocon.com          

Factory Address: Plot No 11, Shendra MIDC, Aurangabad-431154, Maharashtra, India Website:  www.mediocon.com 

Email id:info@mediocon.com           

GST No: 27DHUPM2366D1ZZ

For Dosage Forms :

- Online Marketplaces: You can find Folinic Acid Calcium salt Manufactured by MEDIOCON INC   products on online marketplaces like Amazon or e- commerce websites specializing in pharmaceuticals or skincare products.

Local Pharmacies or Skincare Stores: You can also check with local pharmacies or skincare stores in your area for Folinic Acid Calcium salt Manufactured by MEDIOCON INC products.

Remember to ensure the quality and authenticity of the Folinic Acid Calcium salt Manufactured by MEDIOCON INC product, regardless of the procurement source.