Bitter orange (Citrus aurantium) extract72968-50-4 Manufacturer, supplier, exporter by MEDIOCON INC

 

 

 

Bitter orange (Citrus aurantium) extract Manufactured by MEDIOCON INC

 

   Name: Bitter orange (Citrus aurantium) extract

CAS No :72968-50-4

Molecular Weight:  167.21 g/mol 

Molecular formula:  : C₉H₁₃NO₂

·       Synonyms: Bitter Orange Peel Extract, Sour Orange Extract, Citrus aurantium Amara Peel Extract, Zhi shi (Chinese Traditional Medicine), Synephrine 

 Appearance:  Fine brown-yellow, beige, or brownish-yellow powder

·        Solubility :  Soluble in water and ethanol

·       Odor: Characteristic citrus odor 

 Use :

• Dietary Supplements & Weight Loss: Used to support weight management, increase basal metabolic rate, enhance lipolysis (fat breakdown), and suppress appetite.
• Sports Nutrition: Utilized for energy enhancement and as a stimulant alternative to ephedrine.
• Food Industry: Used as a flavoring agent in beverages, marmalades, and sweets.
• Cosmetics: Used in skincare for its antioxidant and anti-inflammatory properties (e.g., in creams, lotions).
• Traditional Medicine: Used to aid digestion, alleviate bloating, and as a tonic. 

6. Safety and Precautions 

• Contains

pp

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-synephrine, which acts on adrenergic receptors.

• Citrus aurantium extract, when used at recommended doses (often standardized to ~30-50 mg synephrine), is generally considered safe, but may cause increased heart rate or blood pressure in sensitive individuals, particularly when combined with caffeine.

 How is  Bitter orange (Citrus aurantium) extract manufactured by MEDIOCON INC Synthesized?

MEDIOCON INC's Bitter Orange (Citrus aurantium) extract isn't "synthesized" but rather extracted from dried, unripe fruit using processes like water/ethanol extraction or advanced methods (e.g., supercritical fluid, ultrasound) to isolate key compounds like p-synephrine and hesperidin, then purified via resin adsorption, concentration, and crystallization, yielding potent extracts used in supplements. 

Here's a breakdown of typical manufacturing steps:

1.    Raw Material Sourcing: Use dried, immature bitter orange fruits (often the peel) for high concentrations of active ingredients.

2.    Initial Extraction:

·       Solvent Extraction: Using solvents like water and ethanol to dissolve active compounds.

·       Advanced Methods: Techniques like Supercritical Fluid Extraction (SFE) or Ultrasound-Assisted Extraction (UAE) for greener, more efficient extraction.

3.    Purification:

·       Degreasing: Removing oils (like limonene) using petroleum ether.

·       Resin Adsorption: Using specific resins to capture and concentrate target compounds (synephrine, hesperidin).

·       Elution: Washing the resin to release the purified compounds.

4.    Concentration & Crystallization: Evaporating solvents and crystallizing to get pure, powdered extracts (e.g., 98% purity). 

What are the different  dosage forms  of   Bitter orange (Citrus aurantium) extract Manufactured  by  MEDIOCON INC?

Information on specific bitter orange (Citrus aurantium) extract dosage forms manufactured by MEDIOCON INC is not available in the provided search results, which focus on general uses, extraction methods (like alcohol or water extracts), and safety studies of extracts standardized for compounds like p-synephrine, often used in supplements as capsules or added to food/drinks, but not linked to this particular company. To find MEDIOCON INC's specific products, you'd need to check their official website or product listings. 

Here's what the general research indicates about bitter orange extract forms:

·       Dietary Supplements: Commonly found in capsules, tablets, or powders, often standardized for p-synephrine content (e.g., 40-98 mg/day range).

·       Food & Beverage: Used in juices and various food products, as well as enriched drinks (e.g., with caffeine or hydroxycitric acid) for metabolism support.

·       Traditional Uses: Extracts (water, ethanol) have been used in teas and remedies for insomnia, stomach aches, and as laxatives. 

To find MEDIOCON INC's specific dosage forms:

1.    Check MEDIOCON INC's Website: Search for their product catalog or specifications for "Bitter Orange Extract" or Citrus aurantium extract.

2.    Contact the Company Directly: Reach out to their sales or technical department for product details. 

·       Bitter orange (Citrus aurantium L.) extract subchronic 90-day safety ...

The corresponding human equivalent dose (HED) for the 50% p-synephrine-containing bitter orange extract is therefore 18 mg/kg/day.

 

ScienceDirect.com

 

·       A Review of the Human Clinical Studies Involving Citrus aurantium ( ...

The enriched coffee product contained 450 mg caffeine, 21.6 mg p-synephrine, 600 mg hydroxycitric acid and 225 mcg chromium polyni...

 

National Institutes of Health (NIH) | (.gov)

 How Bitter orange (Citrus aurantium) extract Manufactured by MEDIOCON INC   Dosage Forms are prepared?

Based on industrial practices and safety studies of Citrus aurantium (bitter orange) extract—including high-purity, standardized extracts often used in nutraceuticals (e.g., Advantra Z®/Kinetic™ types) similar to those supplied by Mediocon Inc—the manufacturing and dosage form preparation involves a multi-step botanical extraction process. 

1. Manufacturing Process of Bitter Orange Extract

The extract is primarily derived from the dried, immature (green) fruits of Citrus aurantium. 

·       Raw Material Preparation: Immature bitter oranges are dried and ground into powder.

·       Extraction Method: The powder is subjected to solvent extraction, typically using water and/or ethanol. Advanced techniques like ultrasonic-assisted extraction (UAE) or microwave-assisted extraction (MAE) may be used for better efficiency.

·       Standardization for p-Synephrine: The extract is standardized to contain specific percentages of p-synephrine (commonly 4%–90%, with 50% being common for clinical studies).

·       Isolation and Purification: To achieve high concentrations of p-synephrine, the extract is often acidified (e.g., using 0.5% HCl) to convert the compound into soluble hydrochloride. The mixture is passed through a cation exchange resin to bind the alkaloids, washed to remove impurities, and then eluted.

·       Concentration and Drying: The purified extract is concentrated under reduced pressure (vacuum concentration) at temperatures below 80°C to avoid degrading the active components.

·       Final Product: The resulting extract is typically a dry powder, which can be further processed into granules. 

2. Preparation of Dosage Forms

Mediocon Inc supplies the extract for various applications, including pharmaceutical and nutraceutical industries, in formats like powder for capsules or tablets. 

·       Capsules (Dry Powder): The standardized extract powder is blended with excipients (if necessary) to ensure proper flow and consistency. The mixture is filled into capsules using automatic capsule filling machines.

·       Tablets: The extract powder is mixed with binders, fillers (e.g., dicalcium phosphate, microcrystalline cellulose), and disintegrants, then compressed into tablets using a tablet press.

·       Suspension Formulation (for liquid dosage): In research and specialized applications, the dried extract is resuspended in water with a suspending agent, such as 0.5% w/v carboxymethyl cellulose (CMC). 

3. Key Components and Quality Control

·       Active Ingredients: The primary constituents are p-synephrine, along with other protoalkaloids, flavonoids, and hesperidin.

·       Quality Testing: Final products are analyzed using techniques like HPLC (High-Performance Liquid Chromatography), UV, and titration to ensure adherence to standards (IP, BP, USP).

·       Final Form: The product is usually packed in high-density polyethylene (HDPE) drums for industrial use. 

Mediocon Inc acts as a supplier of these extracts, which are produced to meet specific active ingredient percentages (4%–90% Synephrine) as required by clients. 

What are the appropriate Dosage forms of Bitter orange (Citrus aurantium) extract Manufactured  by  MEDIOCON   INC?                

Information on the specific dosage forms of bitter orange (Citrus aurantium) extract manufactured by MEDIOCON INC is not available in the provided search results. However, bitter orange extracts are generally found in several common forms for use in dietary supplements and skincare products. 

Common Forms of Bitter Orange Extract:

Bitter orange extract is typically available in the following forms:

·       Capsules and Tablets: These are common forms for standardized extracts, often used in dietary supplements.

·       Powders: Extract powders can be incorporated into beverages or food items, offering flexibility in how they are consumed.

·       Liquid Extracts or Tinctures: These are sometimes utilized in traditional remedies and certain supplement formulations. 

General Usage and Considerations:

Bitter orange extract is frequently included in dietary supplements, particularly those marketed for weight management. It contains compounds such as p-synephrine. 

It's important to be aware of the following:

·       Stimulant Effects: Bitter orange can act as a stimulant, which is a key consideration, especially for individuals with heart conditions or sensitivity to stimulants.

·       Potential Interactions: Bitter orange extract may interact with certain medications, including MAOIs, SSRIs, blood thinners, and other stimulants like caffeine.

·       Skincare Use: Beyond dietary supplements, bitter orange extract is also used in topical products like creams and face washes for its potential effects on the skin. 

Recommendation:

To determine the appropriate dosage form and concentration of bitter orange extract manufactured by MEDIOCON INC, it is best to consult the specific product label provided by the company. Before using any bitter orange extract product, it is advisable to consult with a healthcare professional to discuss its suitability and potential effects, particularly if you have any pre-existing health conditions or are taking other medications. 

When should Bitter orange (Citrus aurantium) extract Manufactured by MEDIOCON INC be taken?

Based on general guidelines for Citrus aurantium (bitter orange) extract supplements, which are often used for metabolism and weight management, it is generally recommended to be taken:

·       Early in the morning: To help initiate and sustain metabolic activity.

·       Before a workout: Often consumed about 30–90 minutes before exercise to maximize potential fat-burning and energy.

·       On an empty stomach: Often suggested for better absorption. 

Important Usage and Safety Information:

·       Product Labeling: It is crucial to follow the specific instructions on the Mediocon Inc product label, as concentrations can vary.

·       Avoid at Night: Due to its stimulatory effects, it is not advised to take it at night, as it may disrupt sleep.

·       Avoid with Caffeine: Taking bitter orange with caffeine or other stimulants increases the risk of high blood pressure, fainting, heart attack, and stroke.

·       Consult a Doctor: Individuals with high blood pressure, heart disease, diabetes, or those taking medications should consult a healthcare professional before using it. 

 What are the effects And Side effects of Bitter orange (Citrus aurantium) extract Manufactured by MEDIOCON INC?

Bitter orange (Citrus aurantium) extract, containing synephrine, is used for weight loss and metabolism, potentially increasing energy expenditure, but it carries risks like increased heart rate, blood pressure, and headaches, especially with stimulants, with rare reports of serious cardiac events; specific manufacturer details for MEDIOCON INC aren't in general databases, but the effects/side effects are linked to the active compound p-synephrine and its interaction with stimulants, so caution is advised. 

Effects (Intended Uses)

·       Weight Management: Increases resting metabolic rate and energy expenditure, aiding modest weight loss, says Healthline.

·       Metabolism: Its active compound, p-synephrine, can stimulate metabolic processes.

·       Traditional Uses: Flower/peel used for indigestion, appetite stimulation, anxiety, and insomnia in traditional medicine, notes Clinical Advisor. 

Side Effects & Risks

·       Cardiovascular: Can raise heart rate and blood pressure; risk increases with stimulants like caffeine, potentially leading to heart attack, stroke, or angina, according to WebMD and ScienceDirect.

·       Neurological: May trigger headaches, migraines, or cluster headaches in some individuals, says WebMD.

·       Gastrointestinal: Some studies note transient discomfort like head-burrowing in rats at high doses, according to ScienceDirect.

·       Drug Interactions: Can interact with blood pressure medications (like felodipine) and potentially decrease the body's ability to clear them, according to RxList.

·       FDA Status: Banned in some sports supplements in the U.S. due to safety concerns, reports Healthline. 

Regarding MEDIOCON INC

·       While studies show general safety at certain doses (e.g., 1000 mg/kg/day for 90 days showed high safety with reversible effects in rats), according to ScienceDirect specific product data from this manufacturer isn't readily available in these results, according to ScienceDirect so general precautions for bitter orange apply. 

  How is Bitter orange (Citrus aurantium) extract Manufactured by MEDIOCON  INC  Tested Qualitatively?

 

1.    Chromatographic Techniques (HPLC & GC/MS):

·       HPLC: Used to separate, identify, and quantify active compounds, especially phenolic compounds, flavonoids, and alkaloids, confirming their presence and concentration in the extract.

·       GC/MS: Analyzes volatile compounds, helping to determine the oil's composition and authenticate the plant source.

2.    Chemical Identification Tests:

·       Specific chemical tests confirm the presence of classes like glycosides, saponins, phenols, and coumarins, indicating the extract's phytochemical profile.

3.    Botanical Authentication:

·       Microscopic examination and macroscopic features ensure the extract comes from the correct Citrus aurantium plant and not adulterants.

4.    Safety & Purity Tests (Pharmacopoeial Standards):

·       Microbiological Analysis: Checks for harmful bacteria, yeasts, and molds (e.g., using Mueller-Hinton agar).

·       Heavy Metal Testing: Detects levels of lead, mercury, arsenic, and cadmium.

·       Pesticide Residue Analysis: Ensures compliance with safety limits for agricultural chemicals. 

How These Methods Apply to an Extract:

·       Purity: Ensuring it's just bitter orange, not mixed with other citrus or fillers.

·       Identity: Confirming the extract contains expected bitter orange constituents.

·       Strength/Potency: Quantifying the main active ingredient, like p-synephrine, for dosage consistency.

For a company like MEDIOCON INC, these tests ensure the Citrus aurantium extract consistently meets quality benchmarks for safety and efficacy, particularly if used in supplements or food products. 

   Which tests are performed on Bitter orange (Citrus aurantium) extract Manufactured by  MEDIOCON INC ?

While specific details for MEDIOCON INC.'s Citrus aurantium extract aren't public, typical quality control involves testing for p-synephrine content (standardization) via HPLC and confirming safety through microbial tests, heavy metals, and mutagenicity (Ames test), ensuring it meets industry standards for purity, potency, and safety for use in dietary supplements. 

Key Tests Generally Performed on Bitter Orange Extracts:

1.    Identification & Quantification:

·       HPLC (High-Performance Liquid Chromatography): Used to measure the precise amount of the active compound, p-synephrine, ensuring each batch meets the specified concentration (e.g., 50% p-synephrine).

2.    Purity & Contaminants:

·       Heavy Metal Testing: Checks for lead, mercury, arsenic, and cadmium using techniques like ICP-MS.

·       Microbial Testing: Ensures compliance with USP standards for yeast, mold, E. coli, Salmonella, etc..

·       Residual Solvent Analysis: Verifies that extraction solvents are within safe limits.

3.    Safety & Efficacy:

·       Ames Test: Assesses mutagenicity (potential to cause DNA mutations) in bacterial strains (like Salmonella typhimurium).

·       Toxicity Studies (Acute/Subchronic): Animal studies (rats/mice) to determine safe dosage levels and observe any adverse effects (e.g., on organ function, body weight).

·       Assay for Other Amines: Testing for other related amines like octopamine, synephrine, and tyramine using LC-MS/MS. 

How to Find MEDIOCON INC.'s Specific Data:

·       Contact MEDIOCON INC. Directly: The most reliable source for their specific Certificate of Analysis (CoA) is their official customer support or sales department.

·       Check Product Documentation: Look for detailed specs or CoAs on Kisalaya Herbals or other suppliers if they distribute it. 

What are the challenges in Manufacturing of Banana Extract Manufactured by MEDIOCON   INC API?

Manufacturing banana extract faces challenges like ensuring consistent raw material quality (variety, ripeness), optimizing extraction methods (solvent choice, heat sensitivity), achieving high yield/purity, managing significant biomass waste, and ensuring scalability, with specific issues arising from the inherent variability in natural fibers, potential for microbial contamination, and the need for eco-friendly processes for industrial viability, especially for complex APIs. 

Raw Material & Supply Chain Challenges

·       Variability: Banana varieties (e.g., Cavendish, Robusta) and even different parts (peel, pseudostem, leaf) have varying compositions, impacting extract quality.

·       Waste Management: Huge amounts of biomass are generated, requiring effective processing to avoid environmental issues like odor and contamination.

·       Supply Consistency: Maintaining a steady supply of specific, high-quality banana byproducts (like peels or pseudostems) can be logistically complex. 

Processing & Extraction Challenges

·       Bioactive Compound Extraction: Optimizing conditions (solvents, temperature, pressure, time) to maximize desired compounds (phenolics, fibers) while minimizing degradation is crucial.

·       Solvent Issues: Traditional organic solvents (ethanol, methanol) pose safety, cost, and regulatory hurdles; water-based extraction is greener but needs optimization.

·       Fiber Processing (for fiber-based extracts): High fiber content can make extrusion stiff and prone to breakage; pre-drying is essential but adds time.

·       Scalability & Efficiency: Lab-scale success doesn't always translate to industrial efficiency, with slower processing speeds often required for quality. 

Quality & Purity Challenges

·       Heat Sensitivity: Many bioactive compounds degrade with heat, necessitating gentle extraction, which conflicts with faster processing needs.

·       Microbial Growth: Banana byproducts are prone to microbial contamination, requiring careful handling and preservation.

·       Purification: Isolating specific compounds from complex plant matrices is inherently challenging. 

Sustainability & Environmental Challenges

·       Waste Valorization: Turning large volumes of byproduct into valuable products efficiently and economically is key to sustainability.

·       Energy Consumption: Industrial extraction processes can be energy-intensive. 

For MEDIOCON INC. API (Hypothetical Specifics)

·       Specific API Requirements: The specific API (Active Pharmaceutical Ingredient) dictates purity, concentration, and stability needs, adding unique process demands.

·       Regulatory Compliance: Meeting pharmaceutical standards (GMP, safety) for the extract's final use adds layers of complexity and documentation. 

Key Solutions & Research Areas

·       Advanced Techniques: Ultrasound-assisted extraction (UAE), microwave-assisted extraction (MAE), and supercritical fluid extraction (SFE) are explored to improve efficiency and reduce solvent use.

·       Biorefinery Approach: Treating banana waste as a biorefinery feedstock to extract multiple valuable components (fiber, starch, bioactives). 

What are the challenges in manufacturing of Bitter orange (Citrus aurantium) extract Manufactured by MEDIOCON  INC ’s Dosage forms?

Based on the provided search results, the challenges in manufacturing Bitter orange (Citrus aurantium) extract, which is often used in dietary supplements (including those handled by intermediate suppliers like Mediocon Inc), center around standardization, stability, and handling the raw plant material. 

Key Manufacturing and Formulation Challenges:

·       Standardization and Consistency: A major challenge is that bitter orange extracts can be poorly standardized, making it difficult to establish reproducibility in active compounds like p-synephrine. The active compound content (synephrine) can vary, typically ranging between 3% and 6% in dried fruit extracts.

·       Hygroscopic Nature: The dried extract is a light brownish, hygroscopic powder. This means it absorbs moisture from the air, which can cause clumping, handling difficulties, and potential stability issues in dosage forms like tablets and capsules.

·       Active Ingredient Degradation: The extraction process often involves drying immature fruits, which can degrade sensitive compounds. The extract must be protected from heat and humidity to maintain its potency and shelf life (typically 24-36 months).

·       Contamination Risks: Because it is a botanical product, it requires rigorous monitoring for heavy metals (lead, arsenic, cadmium) and microbial contamination (Salmonella, E. coli, yeasts, and molds).

·       Interaction with Other Ingredients: Bitter orange is often formulated in "ephedra-free" blends, but its primary alkaloid, synephrine, can interact with other ingredients, such as caffeine, complicating the formulation process.

·       Extraction Method Limitations: Traditional extraction methods can require long maceration times, large volumes of organic solvents, and high energy usage. 

What is the Packing for Bitter orange (Citrus aurantium) extract Manufactured by MEDIOCON INC?

MEDIOCON INC's Bitter orange (Citrus aurantium) extract is typically packed in inner double plastic bags inside fiber drums, with common bulk sizes being 25kg, but they also offer smaller packs like 5kg or 1kg aluminum foil bags, with specifications often including food/pharma grade, and can be customized per buyer demand, often featuring HDPE drums for larger orders. 

Standard Packaging Options:

·       Bulk: 25kg in a fiber drum (with inner double plastic bags).

·       Smaller Quantities: 5kg or 1kg in aluminum foil bags (with inner double plastic bags).

·       Custom: As per demand, possibly in HDPE drums. 

Key Features:

·       Grades: Available in food grade, pharmaceutical grade, and for veterinary use.

·       Material: Uses food-grade inner plastic bags for hygiene, sealed within outer containers like drums or foil bags.

·       Customization: Packaging can often be adjusted based on specific customer needs, notes Tradeindia. 

What is shelf life Of Bitter orange (Citrus aurantium) extract Manufactured by MEDIOCON INC? 

While specific data for MEDIOCON INC. isn't available in the snippets, standard Citrus aurantium (Bitter Orange) extract generally has a shelf life of 2 to 3 years (24-36 months) when stored properly in cool, dry, dark conditions, sealed in its original packaging, to maintain potency, as seen with other suppliers like Nutraceuticals Group and Kisalaya Herbals. 

Key Factors for Shelf Life:

·       Storage Conditions: Cool, dry, dark, away from direct light.

·       Packaging: Sealed HDPE drums or foil bags help preserve quality.

·       Manufacturer Specifications: For precise information, you should check the product's Certificate of Analysis (CoA) or contact MEDIOCON INC. directly, as shelf life can vary slightly by processing and formulation. 

To confirm the exact shelf life for the product from MEDIOCON INC., consult their product documentation or customer support. 

Where can Bitter orange (Citrus aurantium) extract Manufactured by MEDIOCON INC are procured?

Bitter orange (Citrus aurantium) extract 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 Bitter orange (Citrus aurantium) extract 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 Bitter orange (Citrus aurantium) extract Manufactured by MEDIOCON INC products.

Remember to ensure the quality and authenticity of the Bitter orange (Citrus aurantium) extract Manufactured by MEDIOCON INC product, regardless of the procurement source.