Comprehensive Regulatory & Technical Profile of KETOPROFEN SODIUM STERILE (CAS No. 27210-08-8) Manufactured by Swapnroop Drugs & Pharmaceuticals 🏭📄

 


Q1: What are the regulatory certifications and compliance standards followed for KETOPROFEN SODIUM STERILE by Swapnroop Drugs and Pharmaceuticals? 🏥📋🔬

Swapnroop Drugs and Pharmaceuticals ensures that KETOPROFEN SODIUM STERILE complies with international regulatory and quality standards to support global supply and regulatory filings. Here’s a detailed breakdown of the typical regulatory certifications and compliance measures followed:

🏢 1. GMP (Good Manufacturing Practices) Certification

  • Complies with WHO-GMP, and possibly EU-GMP or US FDA cGMP depending on market.

  • Ensures aseptic manufacturing under sterile conditions. 🧴🧪

  • Facilities inspected for compliance with Schedule M under Indian regulations.

📑 2. ISO Certifications

  • Likely holds ISO 9001:2015 for quality management systems.

  • May also be certified for ISO 14001 (Environmental) and ISO 45001 (Occupational Health & Safety) 🌱⚠️

🧬 3. Regulatory Filings & Documentation

  • Drug Master File (DMF) or Active Substance Master File (ASMF) may be available for registration in the US, EU, or ROW countries. 📁

  • Common Technical Document (CTD) modules can be prepared for international submissions.

🧫 4. Sterility and Aseptic Assurance

  • Manufactured in classified cleanrooms (ISO Class 5–8) with proper environmental controls. 🧼💨

  • Regular microbial monitoring, HEPA filtration, and validation of sterilization methods (like autoclaving or filtration) are followed.

🌍 5. Environmental & Safety Compliance

  • Adheres to local Pollution Control Board (PCB) regulations.

  • Waste and effluent management protocols in place for sterile production residues. ♻️💧

📦 6. Packaging & Labeling Compliance

  • Sterile dosage forms like injections are packed in vials/ampoules under strict regulatory supervision. 🧃

  • Labels meet pharmacopoeial standards (USP/EP/IP) and country-specific norms for regulated markets.

🧾 7. Pharmacopoeial Standards

  • Product typically conforms to USP or EP standards for KETOPROFEN SODIUM STERILE.

  • Includes compliance with tests like sterility, endotoxins, particulate matter, pH, osmolarity, and potency.

Q2: What is the Drug Master File (DMF) or Active Substance Master File (ASMF) status of KETOPROFEN SODIUM STERILE? 📁🧪🌍

📌 Current Status:

Swapnroop Drugs and Pharmaceuticals may maintain or support submission of a Drug Master File (DMF) or Active Substance Master File (ASMF) for KETOPROFEN SODIUM STERILE, especially when supplying to regulated markets like the US, EU, Canada, Australia, or Japan.

🗃️ 1. DMF (US-FDA)

  • A Type II DMF for KETOPROFEN SODIUM STERILE would contain:

    • Manufacturer's details 🏭

    • Route of synthesis and specifications 🧪

    • Control of critical steps and intermediates

    • Sterility assurance and aseptic process validation 💉

  • DMF may be referenced by ANDA/NDA filers in the U.S.

  • DMF submission is done via FDA’s ESG (Electronic Submissions Gateway).

📑 2. ASMF (Europe)

  • For EMA/EDQM filings, a European ASMF (similar to DMF) may be provided.

  • Includes:

    • Open part (for applicants) 📄

    • Restricted part (for regulatory authorities only) 🔒

  • Required when marketing in countries like Germany, France, UK, etc.

🌏 3. Other Market Submissions

  • Canada (Health Canada): DMS submission pathway.

  • Japan (PMDA): Requires English-translated documents and GMP compliance audit.

  • TGA (Australia): Site registration + data package accepted via overseas GMP clearance.

✅ 4. Certification Support

  • Swapnroop may provide:

    • Certificate of Suitability (CEP) if compliant with Ph. Eur.

    • Technical Package for CTD submissions (Module 3: Quality).

    • Stability data under ICH conditions (e.g., 25°C/60% RH and 40°C/75% RH).

💬 Summary:

🔹 If you plan to register or import KETOPROFEN SODIUM STERILE, you can request:

  • The DMF/ASMF number

  • Letter of Access (LOA) ✉️

  • Full regulatory support for dossier compilation


Q3: What are the key regulatory certificates available for KETOPROFEN SODIUM STERILE? 📜✅🌍

🔖 Common Regulatory Certificates Provided by Swapnroop:

  1. Certificate of Analysis (CoA) 📊

    • Batch-specific test results

    • Confirms compliance with pharmacopeial or internal specifications

  2. Good Manufacturing Practice (GMP) Certificate 🏭🧼

    • Issued by regulatory bodies like:

      • WHO (World Health Organization)

      • Local FDCA or international bodies (e.g., EU, TGA, USFDA)

    • Indicates the facility follows stringent manufacturing standards

  3. Certificate of Suitability (CEP) 📄

    • If compliant with Ph. Eur., Swapnroop may apply or possess a CEP from EDQM

    • Facilitates API registration in Europe

  4. Written Confirmation (WC) ✍️

    • Required for EU imports from non-EU countries

    • Confirms GMP compliance for API manufacturing

  5. ISO Certifications 🧩

    • May include ISO 9001:2015 (Quality Management Systems)

    • Ensures standardized documentation and risk-based approach

  6. USDMF Number (if filed) 🧾

    • If submitted, comes with Letter of Access (LOA) to share with your regulatory submission

✅ How to Request These:

  • Email Swapnroop with a formal inquiry

  • Mention product name + intended market + specific regulatory needs

  • Example: “We request GMP certificate, WC, and CoA for KETOPROFEN SODIUM STERILE for submission in [target country]”

Q4: What is the typical packaging and labeling specification for KETOPROFEN SODIUM STERILE? 📦🏷️

📦 Bulk Packaging Options:

  • Double polyethylene bags inside:

    • HDPE drums (25 kg)

    • Fiber drums with tamper-proof seals

  • May include inert gas flushing for moisture-sensitive APIs

  • Tamper-evident closures or metal crimp-sealed drums for sterility 🔐

🏷️ Label Includes:

  • Product Name: KETOPROFEN SODIUM STERILE

  • Batch Number

  • Manufacturing Date / Expiry Date

  • Net Weight

  • Storage Conditions ❄️ (e.g., “Store below 25°C, protect from light”)

  • Manufacturer’s name and address

  • Pharmacopoeial grade (e.g., “USP”, “BP”, “EP”)

🧊 Storage & Transport:

  • Typically shipped under controlled room temperature (CRT)

  • Cold chain may be required depending on regional regulations or sterility requirements

  • Comes with COA + transport declaration



Q5: What is the DMF (Drug Master File) status of KETOPROFEN SODIUM STERILE filed by Swapnroop? 📂🇺🇸🇪🇺

🔍 DMF (Drug Master File) is a confidential document submitted to regulatory authorities like USFDA, EDQM, TGA, etc., that contains proprietary information on the API’s manufacturing, quality control, and stability.

✅ Possible Status Scenarios for KETOPROFEN SODIUM STERILE:

  1. USDMF (Type II) Filed with FDA 🇺🇸

    • If Swapnroop has filed a USDMF, they will have:

      • DMF number (e.g., 012345)

      • Submission status (Active/Inactive)

      • Letter of Access (LOA) can be provided upon request

  2. EDMF/CEP Filed in Europe 🇪🇺

    • If filed via European Directorate for the Quality of Medicines (EDQM):

      • A CEP number will be issued

      • Facilitates product registration in EU

  3. Health Canada / TGA / PMDA DMFs 🇨🇦🇦🇺🇯🇵

    • Swapnroop may also have country-specific DMFs for:

      • Canada, Australia, Japan, Brazil, etc.

  4. If Not Filed: ❌

    • They may offer:

      • Open Part (Technical Package) for regulatory submission

      • Commitment to file a DMF upon client requirement

📩 How to Confirm:
Send a formal inquiry to Swapnroop requesting:

"Kindly confirm the DMF status of KETOPROFEN SODIUM STERILE and provide DMF/CEP number and LOA availability for submission in [target country]."

Q6: What is the stability data and retest period for KETOPROFEN SODIUM STERILE? ⏳🧪📦

📁 Stability Data Includes:

  • Accelerated Studies:

    • 40°C ± 2°C / 75% RH ± 5% for 6 months

  • Long-Term Studies:

    • 25°C ± 2°C / 60% RH ± 5% for up to 24–36 months

    • Per ICH guidelines (Q1A)

🧴 Packaging for Stability Testing:

  • Sealed in commercial HDPE drums or glass vials

  • Protects from moisture and light

⏳ Typical Retest Period (under controlled conditions):

  • 24 to 36 months (depending on validated stability data)

  • Provided on Certificate of Analysis (CoA) or Stability Summary

⚠️ Storage Instructions:

  • Store below 25°C

  • Protect from light and moisture

  • Maintain sterility—store in dry, clean area

📌 Tip: You can request a Stability Summary Report or Stability Protocol from Swapnroop for your regulatory or formulation development needs.


Q6: What is the stability data and retest period for KETOPROFEN SODIUM STERILE? ⏳🧪

🔬 Stability Data (as per ICH guidelines):
Swapnroop likely follows ICH Q1A(R2) for API stability testing.

Typical conditions tested:

  • Accelerated Stability:

    • 40°C ± 2°C / 75% RH ± 5% for 6 months

  • Long-Term Stability:

    • 25°C ± 2°C / 60% RH ± 5% for 12–36 months

  • Intermediate (if needed):

    • 30°C ± 2°C / 65% RH ± 5%

📦 Container-Closure System:

  • Typically packed in double polyethylene bags inside fiber drums or sterile containers.

  • Protected from moisture and light.

📅 Retest Period (Typical):

  • 24 to 36 months if stored as recommended.

  • Confirmed by real-time and accelerated data.

📄 You can request:

  • Full stability summary

  • Storage conditions

  • Certificate of Analysis (CoA) indicating retest date

Q7: What packaging options are available for KETOPROFEN SODIUM STERILE? 📦🧴

Swapnroop usually offers pharma-compliant bulk packaging for sterile APIs. Common options:

✅ Sterile Packaging Formats:

  1. Double LDPE Bags inside a sterilized HDPE drum 🛢️

  2. Sterile Glass Vials (if small quantities required for R&D) 💉

  3. Triple-layer sterile pouches (custom request)

🔒 Sterility Assurance:

  • Packaging conducted under Class 100 cleanroom conditions

  • With sterilization validation (e.g., gamma irradiation or filtration)

📦 Labeling Includes:

  • Product name

  • Batch/Lot number

  • Net weight

  • Retest date

  • Storage condition

  • Manufacturer info (Swapnroop)

📤 MOQ & Custom Options:

  • Standard: 1 kg, 5 kg, 10 kg

  • Custom packaging sizes available on request

📨 Tip: Ask for a Packaging Specification Sheet or photos of packaging if required for QA or tech transfer.



Q8: What are the impurity profile and residual solvent limits for KETOPROFEN SODIUM STERILE? ⚗️📊

🧪 Impurity Profile (based on ICH Q3A/B guidelines):

  1. Related Substances (Organic Impurities):

    • Typically reported in the Certificate of Analysis (CoA)

    • Impurities like:

      • 4-isobutylacetophenone

      • Benzoic acid derivatives

      • Ketoprofen related compound A, B, C... (per pharmacopeia)

  2. Limits (typical values):

    • Individual impurity: NMT 0.10–0.20%

    • Total impurities: NMT 0.50–1.0%

    • Unspecified impurity: NMT 0.10%
      (Values vary depending on the monograph used — USP/EP/IP)

🔍 Techniques Used:

  • HPLC with UV detection

  • GC if volatile impurities are suspected

💨 Residual Solvents (per ICH Q3C):

Swapnroop likely ensures Class 3 solvents only or complete removal of Class 1/2 solvents.

Common solvents checked:

  • Methanol: Limit NMT 3000 ppm

  • Acetone: NMT 5000 ppm

  • Ethanol: NMT 5000 ppm

✅ Analytical Method: GC with headspace analysis
✅ Results: Typically below detection limit or within safe limits

📄 Ask for:

  • Impurity profile document

  • Validation method for HPLC & GC

  • ICH compliance statement

Q9: What is the DMF (Drug Master File) status of KETOPROFEN SODIUM STERILE? 📁🔐

📌 DMF Status with Swapnroop Drugs and Pharmaceuticals:

  • Type II US-DMF: Likely maintained or in progress for regulated markets

  • EU ASMF (Active Substance Master File): May be available for Europe

  • Canadian DMF / Japan DMF: Possible based on exports

📍 What you can request:

  1. Open Part (for customers):

    • Contains CMC data like manufacturing process, specs, and controls

  2. Letter of Access (LoA):

    • Needed if you’re filing in the US, EU, etc.

  3. DMF Number (if filed with US FDA)

    • Allows cross-reference during NDA/ANDA filing

📬 To confirm: Request a copy of the DMF status letter or an Access Authorization Letter

📢 Tip: You may also ask if the API is pre-qualified by WHO or any regulatory approvals (like ANVISA, KFDA).


Q10: What are the stability data and recommended storage conditions for KETOPROFEN SODIUM STERILE? 🧪❄️

📊 Stability Data (ICH Guidelines):

Swapnroop likely follows ICH Q1A(R2) for generating real-time and accelerated stability data.

  1. Accelerated Stability Conditions:

    • 40°C ± 2°C / 75% RH ± 5% RH

    • Duration: 6 months

    • Observations:

      • No significant degradation

      • Impurities within acceptable limits

      • Appearance, assay, and pH remain stable

  2. Long-Term Stability Conditions:

    • 25°C ± 2°C / 60% RH ± 5% RH or
      30°C ± 2°C / 65% RH ± 5% RH

    • Duration: 12–24 months

    • Confirms product is stable over its shelf life

  3. Photostability Testing (ICH Q1B):

    • Conducted to ensure the API is not light-sensitive

    • Packaging in light-resistant containers if required

📎 Stability studies cover:

  • Assay

  • Impurities

  • Moisture content

  • Appearance & pH

🌡️ Recommended Storage Conditions:

  • Store below 25°C

  • Keep tightly closed in a cool, dry, light-protected place

  • Avoid exposure to moisture and direct sunlight

📦 Primary packaging: Usually in sterile vials or HDPE containers with desiccants

🧊 If it's for parenteral formulation, sterility and temperature sensitivity are critically controlled.

Q11: What are the packaging specifications for KETOPROFEN SODIUM STERILE? 📦📋

📦 Typical Packaging Specifications from manufacturers like Swapnroop:

  1. Packaging Types:

    • HDPE containers (with tamper-evident cap) for bulk API

    • Double polyethylene bags sealed inside HDPE drums

    • For sterile APIs: Glass vials (Type I), sealed under sterile conditions

  2. Pack Sizes:

    • 1 kg / 5 kg / 10 kg / 25 kg

    • Customized packs also possible for regulatory or formulation batches

  3. Label Includes:

    • Product name: KETOPROFEN SODIUM STERILE

    • Batch no., Mfg. & Exp. date

    • Net weight

    • Storage instructions

    • Manufacturer’s name & address

    • GMP compliance label (if applicable)

🧴 Sterility Assurance:

  • Packed in cleanroom environment (Grade A/B)

  • Validated aseptic processes if used for injectables

🛡️ Transport Guidelines:

  • Shipped under controlled ambient conditions

  • Temperature logger used for large consignments


Q11: What are the packaging specifications for KETOPROFEN SODIUM STERILE? 📦🧪

Swapnroop Drugs & Pharmaceuticals follows GMP and ICH Q7 standards for packaging sterile APIs like KETOPROFEN SODIUM STERILE to ensure product integrity, sterility, and regulatory compliance.

📦 Primary Packaging Components:

  1. Material Type:

    • Double-layer polyethylene bags (inner sterile bag + outer bag)

    • Placed inside HDPE drums or aluminum containers

  2. Sterile Handling:

    • Primary packaging done in ISO Class 5 (Grade A/B) cleanroom conditions

    • Sterile filtration and lyophilization if applicable

  3. Common Pack Sizes:

    • 100 g / 500 g / 1 kg / 5 kg / 10 kg

    • Custom pack sizes available on request

🏷️ Labeling Details:

Each container label typically includes:

  • Product Name: KETOPROFEN SODIUM STERILE

  • CAS No.: 848344-36-5

  • Batch/Lot Number

  • Date of Manufacture / Expiry

  • Net Quantity

  • Storage Conditions: "Store below 25°C in a dry, light-protected environment"

  • Manufacturer Information: Swapnroop Drugs and Pharmaceuticals

  • Sterile API notice

  • GMP / ISO certification logos (if applicable)

🚚 Secondary & Tertiary Packaging:

  • Outer packaging includes fiberboard cartons or metal drums

  • Lined with cushioning to prevent physical damage

  • Desiccant packs to control moisture

  • Tamper-evident seals and void stickers to ensure integrity during transit

🌍 Export Packaging Compliance:

For international shipments:

  • Material Safety Data Sheet (MSDS) and Certificate of Analysis (CoA) enclosed

  • Temperature monitoring devices may be included for sensitive shipments

  • Conforms to UN/IMDG/IATA packaging requirements

Q12: What are the analytical test parameters and their specifications for KETOPROFEN SODIUM STERILE? 🧪📋

Swapnroop Drugs & Pharmaceuticals typically follows in-house validated methods aligned with USP/Ph.Eur/ICH guidelines for KETOPROFEN SODIUM STERILE.

🧬 Typical Analytical Test Parameters:

TestSpecification
AppearanceWhite to off-white powder 💨
SolubilityFreely soluble in water 💧
Identification (IR, UV, HPLC)Should match reference standard peaks 🔍
pH (1% solution)6.5 – 8.5
Water Content (by KF)Not more than 2.0% 💧
Residue on IgnitionNMT 0.5%
Related Substances (by HPLC)Each impurity NMT 0.2%, Total NMT 1.0%
Assay (on dried basis, by HPLC)98.0% – 102.0% 🔬
SterilityMust comply (No growth) ✅
Bacterial Endotoxins (LAL Test)NMT 0.5 EU/mg 🦠
Particle Size (if applicable)D90 ≤ 10 microns (for injectable grade)
Heavy MetalsNMT 10 ppm
Specific Optical Rotation (if optically active)As per in-house spec

✅ Q13: What documentation does Swapnroop provide with KETOPROFEN SODIUM STERILE? 📄📦

Swapnroop provides a comprehensive regulatory and quality documentation dossier with each batch of KETOPROFEN SODIUM STERILE, ensuring compliance and traceability.

📁 Documents Typically Provided:

  1. Certificate of Analysis (CoA) ✅

    • Batch-specific test results

    • Compliance with specifications

  2. Material Safety Data Sheet (MSDS) ☣️

    • Safety, storage, and handling precautions

  3. TSE/BSE Statement 🐄❌

    • Confirmation of absence of animal-derived material

  4. GMP Certificate / Manufacturing License 🏭

    • Issued by relevant authority

  5. Stability Data Summary 📉

    • Long-term and accelerated conditions (if available)

  6. Method of Analysis (MOA) 📖

    • On request, with technology transfer

  7. Sterility & Endotoxin Reports 🧫

    • From microbiology quality control

  8. Declaration of Non-Irradiation / Non-GMO / Allergen-Free 🧾

    • As per international regulatory demand

  9. Packing List and Proforma Invoice 📦

    • With full logistic traceability

  10. Residual Solvent Statement (as per ICH Q3C) 🧪

    • Compliant with Class 1, 2, 3 solvent limits


✅ Q14: What packaging configurations are available for KETOPROFEN SODIUM STERILE? 📦💉

Swapnroop Drugs & Pharmaceuticals offers KETOPROFEN SODIUM STERILE in sterile, GMP-compliant packaging suited for formulation, R&D, and commercial use, especially for injectables. Packaging options ensure aseptic conditions, stability, and regulatory compliance.

📦 Available Packaging Types:

Packaging TypeDetails
💠 Double LDPE BagsPlaced in triple-layer LDPE bag → sealed in aluminum foil pouch → final HDPE container
📤 Glass Amber BottlesSterile-grade, amber glass vials sealed with rubber stopper & aluminum cap
🧊 HDPE/Polypropylene ContainersSterile bulk API under nitrogen atmosphere (for stability)
📍 Custom-Pack OptionsSmall-scale (1g–50g) to large-scale (1kg–25kg) quantities available

💡 Each container is clearly labeled with batch no., manufacturing/expiry dates, and storage instructions.

🌡️ Storage Condition Labeled:

  • Store below 25°C

  • Protect from moisture and light

  • Use aseptic handling procedures

✅ Q15: What are the storage and handling guidelines for KETOPROFEN SODIUM STERILE? ❄️🧴

Proper storage and handling are crucial to maintain sterility and potency of KETOPROFEN SODIUM STERILE.

🧊 Storage Conditions:

ParameterCondition
📦 Temperature2–8°C (Refrigerated) recommended
🌞 LightProtect from light
💧 HumidityKeep in a dry place
🧪 Contamination RiskHandle in aseptic conditions

🛡️ Handling Precautions:

  • 🧤 Use sterile gloves, gowns, and cleanroom procedures

  • 🧫 Always open containers in controlled environment (Class 100 area)

  • 🧪 Avoid direct contact—product is for formulation use only

  • 🚫 Do not use if container seal is broken or shows signs of moisture

  • 🔄 Ensure proper rotation of stock (First Expiry, First Out - FEFO)

📌 All handling should comply with GMP and USP <797> guidelines for sterile APIs.


✅ Q16: What regulatory documentation and compliance certificates are available for KETOPROFEN SODIUM STERILE manufactured by Swapnroop Drugs and Pharmaceuticals? 📄✅

Swapnroop Drugs & Pharmaceuticals provides a complete regulatory support dossier and key certifications for KETOPROFEN SODIUM STERILE to ensure global compliance and smooth registration across multiple regulated and semi-regulated markets 🌍.

📚 Available Regulatory Documents:

Document TypeAvailability 📌Description
🧾 Certificate of Analysis (CoA)✅ AvailableConfirms identity, purity, potency, pH, sterility, endotoxins, and other critical attributes.
🧪 Sterility Testing Report✅ AvailablePerformed as per USP/BP/EP to confirm product sterility.
📉 Batch Manufacturing Record (BMR)✅ AvailableCovers detailed batch process flow, critical parameters, and traceability.
🔍 Method of Analysis (MoA)✅ AvailableIncludes validated testing protocols (HPLC, UV, pH, LOD, etc.).
🛡 TSE/BSE Certificate✅ AvailableConfirms absence of animal-derived materials or origin risk.
⚗️ Elemental Impurities Statement✅ AvailableAs per ICH Q3D guidelines.
📦 MSDS / SDS (Safety Data Sheet)✅ AvailableDetails safe handling, storage, and disposal procedures.
📃 Product Technical Data Sheet✅ AvailableContains detailed product characteristics and specifications.
📁 DMF (Drug Master File)❌ Not Available/Under preparationCurrently not filed with USFDA/EDQM but can be supported upon request.
💼 GMP Compliance Certificate✅ AvailableIssued by local FDA/Drug Control Authority confirming manufacturing practices.
📋 ISO Certification✅ ISO 9001 & ISO 14001Confirms quality and environmental standards of the manufacturing site.

🔐 Regulatory Support Offered:

  • ✍️ Open Part (for dossier filing)

  • 📧 Query Response for RA departments

  • 🧾 eCTD-format documentation upon request

  • 🌍 Support for countries requiring WHO-GMP / COFEPRIS / ANVISA documentation

🧠 Note: For specific markets (EU, LATAM, MENA, CIS), the documentation set can be customized. Swapnroop also provides Audit support and LOA/LOI issuance for registration filings




 https://wa.me/+919420294801



info@swapnroop.com  

Location: d, J8CW+7C8, 187, Kagal 5 Star MIDC Industrial Area, Halsavade, Maharashtra 416236, India

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