D- Alanine 338-69-2 Manufacturer Exporter MEDIOCON INC

 

D- Alanine Manufactured by MEDIOCON INC     

 

·   Name: D- Alanine

 

·   CAS No: 338-69-2

 

 

·   Molecular Weight: 89.09 g/mol

 

·   Molecular formula:  C₃H₇NO₂

 

·   Synonyms:  (R)-2-aminopropionic acid, D-2-aminopropionic acid, and D-Ala

 

·   Appearance : white to pale cream colored crystalline powder or powder

 

·   Solubility :    soluble in water.

    

·   Use :

D-Alanine is a non-essential amino acid with various applications:

 

Biological Role:

 

1. Bacterial cell wall synthesis: D-Alanine is a component of peptidoglycan, essential for bacterial cell wall structure.

2. Neurotransmission: D-Alanine may play a role in neurotransmission and synaptic plasticity.

 

Industrial Applications:

 

1. Pharmaceuticals: D-Alanine is used in the synthesis of certain antibiotics and pharmaceuticals.

2. Food industry: D-Alanine is used as a flavor enhancer and in food processing.

3. Biotechnology: D-Alanine is used in biotechnology research and development.

 

Other Uses:

 

1. Cosmetics: D-Alanine is used in some cosmetic products for its skin-conditioning properties.

2. Research: D-Alanine is used as a research tool in various scientific studies.

 

D-Alanine's unique properties make it a valuable compound in various industries.

 

·      How is D- Alanine manufactured by MEDIOCON INC Synthesized?

D-Alanine manufactured by MEDIOCON INC can be synthesized through various methods, including:

 

Chemical Synthesis:

 

1. Resolution of racemic mixtures: Separating D-Alanine from L-Alanine through chemical or enzymatic methods.

2. Asymmetric synthesis: Using chiral catalysts or auxiliaries to selectively synthesize D-Alanine.

 

Fermentation:

 

1. Microbial fermentation: Using microorganisms like bacteria or yeast to produce D-Alanine through fermentation processes.

 

Enzymatic Synthesis:

 

1. Enzymatic resolution: Using enzymes like racemases or amidases to selectively synthesize D-Alanine.

 

The specific synthesis method used by MEDIOCON INC would depend on factors like cost, efficiency, and product quality requirements.

 

·         What are the different dosage forms of D- Alanine Manufactured by MEDIOCON INC?

Unfortunately, I couldn't find information on the specific dosage forms of D-Alanine manufactured by MEDIOCON INC. However, D-Alanine is commonly used in various applications, including pharmaceuticals and biotechnology. Typical dosage forms for pharmaceuticals or supplements might include:

- Capsules: Containing powdered D-Alanine for oral consumption

- Tablets: Compressed D-Alanine with other ingredients for oral use

- Powders: Pure D-Alanine powder for mixing with liquids or other products

- Injectable: Sterile solutions of D-Alanine for medical use

To confirm the specific dosage forms manufactured by MEDIOCON INC, it's best to contact the company directly or consult their official documentation.

·         How D- Alanine Manufactured by MEDIOCON INC   Dosage Forms are prepared?

 

The preparation of D-Alanine dosage forms manufactured by MEDIOCON INC may involve various processes depending on the specific dosage form. Here's a general overview:

Capsules:

1. Weighing and mixing: D-Alanine powder is accurately weighed and mixed with excipients.

2. Filling: The mixture is filled into capsule shells.

3. Sealing: Capsules are sealed to prevent leakage.

Tablets:

1. Granulation: D-Alanine powder is granulated with excipients.

2. Compression: Granules are compressed into tablets.

3. Coating: Tablets may be coated for stability or aesthetic purposes.

Powders:

1. Weighing and mixing: D-Alanine powder is accurately weighed and mixed with other ingredients (if applicable).

2. Packaging: The powder is packaged in suitable containers.

Injectable:

1. Sterilization: D-Alanine powder or solution is sterilized.

2. Filling: Sterile solution is filled into vials or ampoules.

3. Sealing: Containers are sealed to maintain sterility.

The specific preparation process may vary depending on the dosage form, equipment, and manufacturing protocols used by MEDIOCON INC.

 

·         What are the appropriate Dosage forms of D- Alanine Manufactured  by  MEDIOCON   INC?

The appropriate dosage forms of D-Alanine manufactured by MEDIOCON INC could include¹ ²:

- Solid Dosage Forms:

    - Tablets: Containing D-Alanine and excipients, designed for immediate or extended release.

    - Capsules: Encapsulating D-Alanine in gelatin shells, available in hard or soft capsule forms.

    - Powders: Finely fragmented particles of D-Alanine for oral consumption or other uses.

- Liquid Dosage Forms:

    - Solutions: Liquid medicines containing D-Alanine, suitable for internal or external applications.

    - Suspensions: Biphasic liquid formulations dispersing D-Alanine in a suitable medium.

    - Syrups: Sweet, viscous liquid medicines containing D-Alanine.

- Semisolid Dosage Forms:

    - Ointments: Semisolid preparations for topical application, combining D-Alanine with a suitable base.

    - Gels: Transparent, semisolid dosage forms for external use, containing D-Alanine and gelling agents.

- Parenteral Dosage Forms:

    - Injectables: Sterile solutions or suspensions of D-Alanine for intravenous, intramuscular, or subcutaneous administration.

 

The specific dosage form used would depend on factors such as the intended use, patient needs, and regulatory requirements.

1. Paste or gel forms for specific industrial applications

2. Granular forms for certain food or pharmaceutical applications

 

The choice of dosage form depends on factors like:

 

1. Desired color intensity

2. Product formulation

3. Manufacturing process

4. Regulatory requirements

 

MEDIOCON INC would determine the most suitable dosage form based on customer needs and product specifications.

 

·         When should D- Alanine Manufactured by MEDIOCON INC be taken?

The timing of taking D-Alanine manufactured by MEDIOCON INC depends on the specific product, intended use, and individual needs. Here are some general considerations:

 

General Guidelines:

 

1. With meals: Taking D-Alanine with meals may help reduce gastrointestinal side effects.

2. Consistency: Taking D-Alanine at the same time each day can help maintain consistent levels.

 

Specific Uses:

 

1. Cognitive support: Taking D-Alanine in the morning or early afternoon may be beneficial for cognitive support.

2. Sleep support: Taking D-Alanine before bedtime may be beneficial for sleep support.

 

Consult Instructions:

 

1. Follow product label instructions: MEDIOCON INC's product label or instructions should be followed for specific guidance on timing.

2. Consult a healthcare professional: If unsure about timing or have specific questions, consult a healthcare professional.

 

The optimal timing may vary depending on individual needs and product specifications.

 

·         What are the effects And Side effects of D- Alanine Manufactured by MEDIOCON INC?

D-Alanine, manufactured by MEDIOCON INC, is a non-essential amino acid with various effects and potential side effects.

 

Effects:

 

- Energy Production: D-Alanine plays a role in converting sugar into energy and providing fuel for muscles, brain, and central nervous system.

- Muscle Health: It helps build and repair muscle tissue, making it beneficial for athletes and individuals with high physical activity.

- Blood Sugar Management: D-Alanine may help manage blood sugar levels in people with diabetes by regulating glucose use and preventing low blood sugar.

- Cholesterol Management: It may also help lower cholesterol levels, especially when combined with other amino acids like Arginine and glycine.

- Prostate Health: D-Alanine is found in high concentrations in prostate fluid and may help protect the prostate gland from enlargement and reduce associated pain.¹ ²

 

Side Effects:

 

- Blood Sugar Levels: D-Alanine may increase blood sugar levels, which can be problematic for people with diabetes if not monitored properly.

- Digestive Issues: High doses of amino acids, including D-Alanine, may cause digestive issues.

- Skin and Kidney Effects: It may also cause skin itchiness, tingling, and be hard on the kidneys and liver to process.

 

Precautions:

 

- Pregnancy and Breastfeeding: There isn't enough reliable information to know if D-Alanine is safe to use in larger amounts as medicine during pregnancy or breastfeeding.

- Diabetes: People with diabetes should work with their doctors to monitor their blood sugar levels before taking D-Alanine supplements.

- Dosage: It's essential to follow relevant directions on product labels and consult a healthcare professional before using D-Alanine supplements.

 

·         How is D- Alanine Manufactured by MEDIOCON  INC  Tested Qualitatively?

D-Alanine manufactured by MEDIOCON INC can be tested qualitatively using various analytical techniques, including:

 

Chromatography:

 

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

2. Gas Chromatography (GC): Analyzes D-Alanine's volatility and separation characteristics.

 

Spectroscopy:

 

1. Nuclear Magnetic Resonance (NMR) Spectroscopy: Identifies D-Alanine's molecular structure and purity.

2. Infrared (IR) Spectroscopy: Analyzes D-Alanine's molecular vibrations and functional groups.

 

Other Methods:

 

1. Titration: Determines D-Alanine's concentration through chemical reactions.

2. Enzymatic Assays: Utilizes enzymes to detect D-Alanine's presence and activity.

 

            These qualitative tests help ensure D-Alanine's identity, purity, and quality, meeting regulatory and customer requirements.

 

·         Which tests are performed on D- Alanine Manufactured by MEDIOCON INC?

D-Alanine manufactured by MEDIOCON INC may undergo various tests to ensure its quality, purity, and compliance with regulatory standards. Some common tests include:

Physical Tests:

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

2. Solubility: Testing solubility in various solvents.

Chemical Tests:

1. Purity: Determining the percentage of D-Alanine present.

2. Identity: Confirming the presence of D-Alanine using techniques like HPLC or NMR.

3. Moisture content: Measuring the amount of moisture present.

Microbial Tests:

1. Sterility: Ensuring the product is free from microorganisms.

2. Microbial limits: Testing for the presence of specific microorganisms.

Other Tests:

1. Heavy metals: Testing for the presence of heavy metals like lead, mercury, or arsenic.

2. Impurities: Detecting and quantifying impurities present in the product.

These tests help ensure D-Alanine's quality, safety, and efficacy, meeting regulatory and   

 customer requirements.

·         What are the challenges in Manufacturing of D- Alanine Manufactured by MEDIOCON   INC API?

The manufacturing of D-Alanine API (Active Pharmaceutical Ingredient) by MEDIOCON INC may face several challenges, including:

 

Chemical Challenges:

 

1. Synthesis complexity: D-Alanine's synthesis involves complex chemical reactions, requiring precise control.

2. Purity and yield: Ensuring high purity and yield of D-Alanine can be challenging.

 

Regulatory Challenges:

 

1. Compliance with GMP: Meeting Good Manufacturing Practice (GMP) regulations is crucial for API production.

2. Regulatory approvals: Obtaining necessary approvals and certifications from regulatory bodies.

 

Quality Control Challenges:

 

1. Impurity profiling: Detecting and controlling impurities is essential for API quality.

2. Consistency: Ensuring batch-to-batch consistency in quality and purity.

 

Supply Chain Challenges:

 

1. Raw material sourcing: Sourcing high-quality raw materials can be challenging.

2. Supply chain disruptions: Managing supply chain disruptions and ensuring timely delivery.

 

Technological Challenges:

 

1. Process optimization: Optimizing manufacturing processes for efficiency and cost-effectiveness.

2. Scaling up production: Scaling up production while maintaining quality and consistency.

 

          Addressing these challenges is crucial to ensure the quality, safety, and efficacy of D-  

          Alanine API manufactured by MEDIOCON INC.

 

·         What are the challenges in manufacturing of D- Alanine Manufactured by MEDIOCON  INC ’s Dosage forms?

The manufacturing of D-Alanine dosage forms by MEDIOCON INC may face several challenges, including:

 

Formulation Challenges:

 

1. Stability and compatibility: Ensuring D-Alanine's stability and compatibility with excipients.

2. Solubility and bioavailability: Optimizing solubility and bioavailability for effective dosage forms.

 

Manufacturing Challenges:

 

1. Process control: Maintaining precise control over manufacturing processes.

2. Equipment and technology: Selecting suitable equipment and technology for dosage form production.

 

Quality Control Challenges:

 

1. Content uniformity: Ensuring uniform content of D-Alanine in each dosage unit.

2. Impurity profiling: Detecting and controlling impurities in the dosage form.

 

Regulatory Challenges:

 

1. Compliance with regulations: Meeting regulatory requirements for dosage form manufacturing.

2. Documentation and validation: Maintaining thorough documentation and validation records.

 

Packaging and Stability Challenges:

 

1. Packaging material selection: Selecting suitable packaging materials to ensure stability.

2. Shelf-life determination: Determining the shelf-life of the dosage form.

 

Addressing these challenges is crucial to ensure the quality, safety, and efficacy of D-Alanine dosage forms manufactured by MEDIOCON INC.

·         What is the Packing for D- Alanine Manufactured by MEDIOCON INC?

 

The packing for D-Alanine manufactured by MEDIOCON INC may vary depending on the specific product and intended use. Here are some possible packing options:

 

Common Packing Options:

 

1. Drums: Fiber drums or plastic drums for bulk packaging.

2. Bags: Polypropylene bags or paper bags for smaller quantities.

3. Containers: Intermediate Bulk Containers (IBCs) for larger quantities.

4. Pharmaceutical packaging: Specific packaging for pharmaceutical applications, such as bottles, vials, or blister packs.

 

Packing Specifications:

 

1. Net weight: Specified net weight per container or package.

2. Labeling: Labels indicating product name, manufacturer, and relevant safety information.

3. Storage conditions: Specifications for storage conditions, such as temperature and humidity.

 

The specific packing details would depend on MEDIOCON INC's product specifications, customer requirements, and regulatory compliance.

·         What is shelf life Of D- Alanine Manufactured by MEDIOCON INC? 

The shelf life of D-Alanine manufactured by MEDIOCON INC isn't directly available. However, a similar product, 3-Azido-D-alanine HCl, has a shelf life of 12 months when unopened and stored at 2-8°C in a dry environment. It's likely that D-Alanine would have similar storage requirements and shelf life, but without specific information from MEDIOCON INC, this can't be confirmed.

 

To determine the exact shelf life of D-Alanine manufactured by MEDIOCON INC, consider the following¹:

- Check product labeling: Look for storage instructions and expiration dates on the product label.

- Contact MEDIOCON INC directly: Reach out to the manufacturer for specific guidance on shelf life and storage conditions.

- Consult regulatory documents: Review relevant regulatory documents or certifications, such as those related to Good Manufacturing Practices (GMP), for insights into the product's shelf life.

 

·         What should the label claim for D- Alanine Manufactured by MEDIOCON INC Include?

 

The label claim for D-Alanine manufactured by MEDIOCON INC should include the following information:

 

Product Information:

 

1. Product name: D-Alanine

2. Manufacturer's name: MEDIOCON INC

3. Batch number: Unique batch identifier

 

Composition:

 

1. Active ingredient: D-Alanine

2. Quantity: Amount of D-Alanine per serving or unit

 

Usage and Storage:

 

1. Directions for use: Recommended dosage and administration

2. Storage conditions: Temperature, humidity, and light exposure guidelines

 

Safety Information:

 

1. Warning and precautions: Potential side effects, contraindications, and interactions

2. Allergen information: Presence of allergens or potential allergens

 

Regulatory Compliance:

 

1. Regulatory approvals: Relevant regulatory agency approvals (e.g., FDA, EMA)

2. GMP compliance: Statement indicating compliance with Good Manufacturing Practices

 

Other Information:

 

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

2. Net weight or quantity: Amount of product in the container

 

The label claim should be accurate, clear, and compliant with relevant regulatory requirements.

 

·         Where can D- Alanine Manufactured by MEDIOCON INC are procured?

D- Alanine Manufactured by MEDIOCON INC   can be procured from various sources, depending on your location and requirements. Here are some options:

1.      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

 

2.      For Dosage Forms :

     - Online Marketplaces: You can find D- Alanine 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 D- Alanine Manufactured by MEDIOCON INC products.

 Remember to ensure the quality and authenticity of the D- Alanine Manufactured by MEDIOCON INC product, regardless of the procurement source.