Comprehensive Overview of IMIPENEM AND CILASTATIN SODIUM STERILE (CAS No. 82009-34-5 / 81129-83-1) Manufactured by Swapnroop Drugs & Pharmaceuticals

1. What is IMIPENEM AND CILASTATIN SODIUM STERILE manufactured by Swapnroop Drugs & Pharmaceuticals? 💊💉

IMIPENEM AND CILASTATIN SODIUM STERILE is a broad-spectrum, sterile injectable antibiotic combination manufactured by Swapnroop Drugs & Pharmaceuticals. It is designed to treat moderate to severe bacterial infections by combining two active pharmaceutical ingredients:

Imipenem – a powerful carbapenem-class antibiotic
Cilastatin Sodium – a renal dehydropeptidase inhibitor that protects Imipenem from degradation in the kidneys

This combination enhances the effectiveness and stability of the treatment, making it a go-to option in critical care settings like ICUs. 🏥🧪

🧬 Components Explained:

Component	Role
Imipenem 💥	A β-lactam antibiotic that inhibits bacterial cell wall synthesis by binding to PBPs (penicillin-binding proteins)
Cilastatin 🛡️	Not an antibiotic; it inhibits renal enzyme (dehydropeptidase-I) that would otherwise degrade Imipenem, improving efficacy and half-life

📦 Formulation by Swapnroop Includes:

Sterile lyophilized powder in glass vials
Typically available in strengths like:
- 250 mg + 250 mg
- 500 mg + 500 mg
Intended for intravenous (IV) administration only

🦠 Spectrum of Activity:

✅ Active against:

Gram-positive cocci (e.g., Streptococcus, Staphylococcus)
Gram-negative bacilli (e.g., E. coli, Klebsiella, Pseudomonas)
Anaerobes (e.g., Bacteroides)

🚫 Not effective against:

MRSA
VRE (Vancomycin-resistant Enterococci)
Certain atypicals like Mycoplasma or Chlamydia

🏥 Used In Treatment Of:

Hospital-acquired pneumonia (HAP)
Intra-abdominal infections
Complicated urinary tract infections (cUTIs)
Septicemia
Skin and soft tissue infections
Joint/bone infections
Post-surgical infections

🔒 Why Sterile?

Because it's administered via IV, sterility is critical to prevent systemic infections. Swapnroop ensures sterility through:

Aseptic processing
Sterile filtration (0.22 μm)
Lyophilization (freeze drying)
Sealed packaging with moisture protection

📊 Regulatory Standards Followed:

Complies with USP/EP/BP/IP monographs
Manufactured under GMP-certified facilities
Stability, sterility, and purity validated per ICH Q1–Q6 guidelines

❓ 2. What is IMIPENEM AND CILASTATIN SODIUM STERILE by Swapnroop Drugs and Pharmaceuticals used for? 🏥💉

IMIPENEM AND CILASTATIN SODIUM STERILE, manufactured by Swapnroop Drugs & Pharmaceuticals, is used to treat moderate to severe bacterial infections — particularly in hospital or intensive care unit (ICU) settings where broad-spectrum coverage is essential. It is typically reserved for complicated infections or when other antibiotics fail.

✅ Primary Uses Include:

Infection Type	Examples
🫁 Lower respiratory tract infections	Hospital-acquired pneumonia, ventilator-associated pneumonia
💧 Complicated urinary tract infections	Pyelonephritis, catheter-associated UTIs
🦴 Bone & joint infections	Osteomyelitis, prosthetic joint infections
💉 Septicemia (blood infections)	Bacteremia from resistant Gram-negative organisms
🦠 Intra-abdominal infections	Peritonitis, abscesses, post-surgical infections
🩹 Skin & soft tissue infections	Diabetic foot, cellulitis, necrotizing fasciitis
🤕 Post-operative infections	Wound site infections after abdominal or thoracic surgery
🧬 Empiric therapy	Used before pathogen is identified, esp. in critical illness

🎯 Why This Combo?

Imipenem = powerful bactericidal activity
Cilastatin = protects Imipenem from renal degradation, ensuring longer action and higher efficacy

🛡️ Used Against:

Multi-drug resistant Gram-negative bacteria (like Pseudomonas aeruginosa, Klebsiella pneumoniae)
Gram-positive cocci
Anaerobic bacteria
Extended-spectrum β-lactamase (ESBL) producing organisms

⚠️ Note: It's a reserved antibiotic under antimicrobial stewardship programs — only used when other safer, narrow-spectrum antibiotics are ineffective to avoid resistance.

❓ 3. What are the physicochemical properties of IMIPENEM AND CILASTATIN SODIUM STERILE manufactured by Swapnroop Drugs and Pharmaceuticals? ⚗️🧪

IMIPENEM AND CILASTATIN SODIUM STERILE is a lyophilized (freeze-dried) powder containing a 1:1 molar ratio of Imipenem and Cilastatin, both present as sodium salts. The formulation is optimized to maintain chemical and microbial stability, ease of reconstitution, and compatibility with IV infusion.

⚗️ Key Physicochemical Properties:

Property	Details
📌 Form	Sterile, lyophilized white to off-white powder
🧪 Solubility	Freely soluble in water
⚖️ pH (after reconstitution)	~6.5 to 7.5
💧 Moisture content	NMT 3.0% (measured via Karl Fischer titration)
🧬 Molecular formula	Imipenem C12H17N3O4S · Cilastatin C16H26N2O5S · Na+ (x2)
⚛️ Molecular weights	Imipenem ≈ 299.35 g/mol, Cilastatin ≈ 358.46 g/mol
🌡️ Melting point	Decomposes before melting
🔬 Appearance in solution	Clear, colorless to pale yellow solution after reconstitution
🧯 Thermal sensitivity	Degrades under heat; must be stored at controlled temperatures

🔄 Stability Considerations:

Imipenem is extremely sensitive to hydrolysis — hence, requires Cilastatin to inhibit enzymatic breakdown
The lyophilized form prolongs shelf life by removing water and reducing degradation risk

❓ 4. How is IMIPENEM AND CILASTATIN SODIUM STERILE synthesized by Swapnroop Drugs and Pharmaceuticals? ⚗️🧬

The synthesis of IMIPENEM AND CILASTATIN SODIUM STERILE by Swapnroop Drugs & Pharmaceuticals involves the separate synthesis of Imipenem and Cilastatin Sodium, followed by controlled combination, sterile processing, and lyophilization (freeze-drying). Each step follows strict GMP guidelines and ICH quality standards.

🧪 Synthesis of Imipenem:

Carbapenem core formation
- Starting with β-lactam intermediates derived from penicillanic acid
- Modified to introduce the 1-β-methylcarbapenem ring (enhances stability)
Side chain introduction
- Addition of a hydroxyethyl group and appropriate side chains via stereoselective steps
Purification
- Crystallization or chromatography to remove impurities
Conversion to Imipenem monohydrate
- Final salt adjustment and drying

🧪 Synthesis of Cilastatin Sodium:

Starting from glutamic acid derivatives
- Transformation through amide formation and side chain addition
Dehydropeptidase-I inhibition activity optimized
- Introduction of a thiol-containing functional group
Salt formation
- Final product is Cilastatin Sodium, the stable, water-soluble form

⚗️ Formulation Process:

Weighing & blending
- Imipenem and Cilastatin Sodium are mixed in a 1:1 molar ratio
- Excipients (e.g. sodium bicarbonate or buffers) may be added to maintain pH
Sterile filtration
- Solution is passed through a 0.22 μm membrane filter
Aseptic filling
- Sterile solution is filled into Type I glass vials in a cleanroom
Lyophilization (Freeze-drying) ❄️
- Removes water while preserving chemical integrity
- Prevents hydrolysis and enhances shelf life
Stoppering & sealing
- Rubber stoppers and aluminum seals are applied
- Vials are inspected and packed

🧼 Final product:

A sterile, pyrogen-free lyophilized powder ready for IV reconstitution

❓ 5. What are the different dosage forms of IMIPENEM AND CILASTATIN SODIUM STERILE manufactured by Swapnroop Drugs and Pharmaceuticals? 💉📦

Swapnroop Drugs & Pharmaceuticals produces IMIPENEM AND CILASTATIN SODIUM exclusively in sterile, injectable dosage forms, due to the molecule’s poor oral bioavailability and need for precise dosing in critical infections.

💊 Available Dosage Forms:

Dosage Form	Details
Lyophilized powder for injection	- Most common

Administered via IV infusion after reconstitution |
| Dual-compound single vial | - Contains both Imipenem and Cilastatin Sodium in a fixed ratio (1:1) |
| Combination powder for solution | - Requires dilution with Sterile Water for Injection (SWFI) |

📦 Common Strengths Available:

Imipenem + Cilastatin	Use
250 mg + 250 mg per vial	Pediatric or low-weight adult dosing
500 mg + 500 mg per vial	Standard adult dose for most indications
1 g + 1 g per vial (rarely)	For high-dose or extended-interval regimens

❌ Dosage Forms Not Manufactured:

❌ Oral tablets or capsules (ineffective due to poor absorption and degradation)
❌ Intramuscular forms (painful, unpredictable absorption)
❌ Topical or ocular forms (not indicated)

6. How are IMIPENEM AND CILASTATIN SODIUM STERILE dosage forms prepared by Swapnroop Drugs and Pharmaceuticals? 🏭💉

The dosage forms of IMIPENEM AND CILASTATIN SODIUM STERILE at Swapnroop Drugs & Pharmaceuticals are prepared under strict aseptic and GMP-compliant conditions, primarily as lyophilized powders for injection. The process ensures stability, sterility, and high potency of both active ingredients.

🧪 Step-by-Step Preparation Process:

🧬 1. API Weighing and Dispensing

Accurately weigh Imipenem and Cilastatin Sodium in a 1:1 molar ratio
Use validated scales in a Class 100 cleanroom
Buffering agents (e.g., sodium bicarbonate) may be included

💧 2. Solution Preparation

APIs are dissolved in Water for Injection (WFI)
Maintain pH between 6.5–7.5 for optimal solubility and stability
Stirred under nitrogen or argon blanket to prevent oxidation

🧫 3. Sterile Filtration

The solution is filtered through 0.22 µm sterile filters
This step removes any microbial contamination
Filter integrity testing is performed after filtration

🧴 4. Aseptic Filling

The sterile solution is filled into Type I borosilicate glass vials
Performed inside a Grade A laminar airflow hood
Fill volume is adjusted based on dosage strength (e.g., 20 mL for 500+500 mg)

❄️ 5. Lyophilization (Freeze Drying)

Vials are placed in a lyophilizer (freeze dryer)
Water is sublimated under vacuum at low temperature
End result: dry, porous sterile cake inside each vial

🧪 6. Stoppering and Sealing

After lyophilization, butyl rubber stoppers are inserted
Sealed with aluminum crimp caps to ensure vial integrity

📦 7. Inspection and Labeling

Vials are inspected for cake quality, clarity, and particulate matter
Each vial is labeled with batch number, expiry, barcode, and reconstitution instructions

🔄 In-Process Controls Include:

pH check
Bioburden testing
Fill weight accuracy
Visual inspection
Environmental monitoring (Grade A/B area)

❓ 7. What is the appropriate dosage form of IMIPENEM AND CILASTATIN SODIUM STERILE manufactured by Swapnroop Drugs and Pharmaceuticals? 💊✅

The most appropriate dosage form for this drug combination is the lyophilized sterile powder for intravenous infusion. This is the only pharmaceutically viable and clinically effective form due to the chemical instability of imipenem in solution and its poor oral absorption.

💉 Why IV Lyophilized Form is Ideal:

Reason	Explanation
💧 Stability	Lyophilized form prevents hydrolysis and extends shelf life
💉 Precise dosing	Allows for accurate titration based on patient’s weight and renal function
🚑 Rapid onset	IV administration ensures quick therapeutic plasma levels
🧬 Bioavailability	100% IV bioavailability vs. poor/no absorption orally
🛡️ Aseptic assurance	Vials are sterile and pyrogen-free

📌 Recommended Dosage Form by Strength:

Indication	Formulation
Adult standard use	500 mg + 500 mg lyophilized vial
Pediatric or renal patients	250 mg + 250 mg lyophilized vial
Severe infections (adjusted)	1 g + 1 g vial (less common)

💡 Note: Each vial must be reconstituted with 10–20 mL sterile water and administered over 20–60 minutes via IV infusion.

8. When should IMIPENEM AND CILASTATIN SODIUM STERILE API manufactured by Swapnroop Drugs and Pharmaceuticals be taken? ⏱️💉

IMIPENEM AND CILASTATIN SODIUM STERILE, manufactured by Swapnroop Drugs & Pharmaceuticals, is used only when prescribed by a healthcare professional—primarily in hospital or ICU settings for moderate to severe bacterial infections. It is not taken by mouth but given via intravenous (IV) infusion at scheduled intervals.

⏰ Timing of Administration:

Parameter	Details
💊 Route	Intravenous infusion only
⏳ Frequency	Usually every 6–8 hours, depending on severity and renal function
⚖️ Dose based on	Body weight, infection type, renal clearance (creatinine clearance)
🕐 Duration	Typically 7–14 days or until infection resolves
🧪 Therapeutic use	Often started empirically, adjusted once culture and sensitivity results are available
🧠 Timing considerations	Must be administered on time to maintain constant plasma levels

🧫 Special Situations:

🚼 Pediatric use: Adjusted dose based on body weight
🚨 Renal impairment: Dose interval extended to avoid drug accumulation
🔁 Dialysis patients: Often dosed post-dialysis session

⚠️ Never self-administered. It must be given in a clinical setting by trained personnel under sterile conditions.

❓ 9. What are the effects and side effects of IMIPENEM AND CILASTATIN SODIUM STERILE manufactured by Swapnroop Drugs and Pharmaceuticals? 💥🧬

IMIPENEM AND CILASTATIN SODIUM STERILE is a broad-spectrum antibiotic with strong activity against a wide range of Gram-positive, Gram-negative, and anaerobic bacteria. However, like all potent medications, it carries both therapeutic effects and potential side effects.

✅ Therapeutic Effects (Benefits):

🦠 Effect	Explanation
🔬 Bactericidal action	Kills bacteria by inhibiting cell wall synthesis
🎯 Broad-spectrum coverage	Effective against tough infections like Pseudomonas, ESBLs
🛡️ Resistant to β-lactamases	Active even when penicillins or cephalosporins fail
🧬 Renal protection (via cilastatin)	Cilastatin blocks imipenem degradation, improving effectiveness

⚠️ Common Side Effects:

System	Side Effects
🌡️ General	Fever, headache, injection site pain
🧪 GI tract	Nausea, vomiting, diarrhea, abdominal cramps
🩺 Skin	Rash, pruritus, urticaria
🧠 Nervous system	Seizures (especially in renal-impaired or high-dose)
🩸 Blood	Eosinophilia, thrombocytopenia (rare)

🚨 Serious (but rare) Adverse Reactions:

Seizures (dose-dependent; more common in CNS disorder patients)
Anaphylaxis in penicillin-allergic individuals
Clostridioides difficile-associated diarrhea (CDAD)
Liver enzyme elevations or hepatotoxicity

👩‍⚕️ Monitoring Requirements:

Renal function (serum creatinine, BUN)
Neurologic signs (especially if patient is elderly or renally impaired)
Liver function tests (ALT, AST, bilirubin)
Complete blood count (CBC)

🧠 Tip: Early reporting of side effects helps clinicians adjust dosing or change therapy if needed.

Would you like a detailed side effect incidence chart or a patient counseling guide for this product next?

10. How is IMIPENEM AND CILASTATIN SODIUM STERILE tested by Swapnroop Drugs and Pharmaceuticals? 🔬🧪

Swapnroop Drugs & Pharmaceuticals conducts comprehensive in-process and finished product testing for IMIPENEM AND CILASTATIN SODIUM STERILE to ensure it meets pharmacopeial standards (USP/EP/IP) for sterility, potency, safety, and stability.

🧫 Key Categories of Testing:

Test Type	Purpose
🧪 Chemical testing	Confirms identity, strength, purity of Imipenem & Cilastatin
🔍 Microbiological testing	Ensures product is sterile and free of endotoxins
⚖️ Physical testing	Verifies visual appearance, cake formation, and moisture
🧬 Stability testing	Determines shelf life and degradation profile
🧼 Aseptic validation	Confirms cleanroom and process sterility

🧪 Main Analytical Tests Performed:

Test	Details
✅ Identification (ID)	HPLC, IR Spectroscopy, or TLC methods for both APIs
🧪 Assay (Potency)	HPLC-based quantification of Imipenem & Cilastatin content
⚠️ Related Substances	Detects and quantifies impurities and degradation products
💧 Moisture Content	Karl Fischer titration (must be <3%)
🧂 pH of Reconstituted Soln	Should be within 6.5–7.5 range
🌡️ Reconstitution Time	Must dissolve in sterile water within prescribed time (<5 mins)

❓ 11. What tests are performed on IMIPENEM AND CILASTATIN SODIUM STERILE manufactured by Swapnroop Drugs and Pharmaceuticals? 🧬📊

Here’s a detailed breakdown of in-house quality control tests done during manufacturing, packaging, and release of each batch:

🔬 Finished Product Tests:

Category	Test Name	Purpose
✅ Identity Tests	IR, HPLC retention time matching	Confirms correct APIs (Imipenem & Cilastatin)
🧪 Assay	HPLC (limit: 90–110% of label claim)	Measures drug content (potency)
⚗️ pH	pH meter (6.5–7.5 expected)	Confirms correct formulation environment
💧 Water Content	Karl Fischer (NMT 3.0%)	Ensures dry, stable lyophilized product
🦠 Sterility	USP <71> or Ph. Eur. 2.6.1 method	No microbial growth in 14 days
🧫 Bacterial Endotoxins	USP <85> LAL test (NMT 0.5 EU/mg)	Ensures pyrogen-free product
🧬 Related Substances	HPLC-based impurity profiling	Identifies unknown/known impurities
💊 Reconstitution	Visual clarity, dissolution within 5 mins	Ensures ease of use in hospital settings
👁️ Visual Inspection	Automated/manual detection of particulates	Checks for foreign matter and uniformity

🧪 Stability Testing (ICH Q1A):

Long-term (25°C/60% RH, 30°C/65% RH)
Accelerated (40°C/75% RH)
Evaluates:

Potency
pH drift
Appearance
Impurity rise
Moisture gain

❓ 12. What are the challenges in manufacturing IMIPENEM AND CILASTATIN SODIUM STERILE API by Swapnroop Drugs and Pharmaceuticals? ⚙️🧬

Manufacturing the API (Active Pharmaceutical Ingredient) of IMIPENEM AND CILASTATIN SODIUM STERILE involves numerous technical, chemical, and regulatory challenges. Swapnroop Drugs & Pharmaceuticals must overcome these to ensure purity, potency, and stability of both compounds in the sterile injectable form.

⚠️ Key Challenges in API Manufacturing:

🔄 1. Chemical Instability of Imipenem

Imipenem is highly prone to hydrolysis and degradation in aqueous media
It can self-degrade rapidly, especially at higher temperatures and in acidic/basic pH
Requires strict moisture control and low-temperature synthesis and storage

🧪 2. Complex Synthesis Process

Both APIs require multi-step synthesis routes with precise stereochemistry
Handling of intermediate β-lactams demands specialized containment and equipment
Scale-up of carbapenem core can result in impurity formation or racemization

💥 3. Impurity Control

Controlling related substances, especially β-lactam impurities, is challenging
Cilastatin synthesis must limit residual solvents and thiol-related degradants

💧 4. Hygroscopic Nature

APIs are hygroscopic (absorb moisture quickly), risking hydrolytic degradation
Requires nitrogen blanketing, desiccant storage, and rapid handling post-synthesis

🧼 5. Sterility & Pyrogen-Free Requirements

Even though the API is sterile only after final formulation, clean handling and bioburden control during API steps are essential

📋 6. Regulatory Compliance

Must conform to ICH Q7 (GMP for APIs), and specifications as per USP/EP/JP
Stability data must be generated under ICH guidelines (Q1A–Q1F)

❓ 13. What are the challenges in manufacturing IMIPENEM AND CILASTATIN SODIUM STERILE dosage forms by Swapnroop Drugs and Pharmaceuticals? 🏭💉

Formulating and filling IMIPENEM AND CILASTATIN SODIUM STERILE as a lyophilized injectable is highly complex and demands advanced aseptic manufacturing systems.

🧪 Major Formulation & Dosage Form Challenges:

❄️ 1. Lyophilization Complexity

Lyophilization (freeze drying) requires:
- Precise temperature & vacuum control
- Preventing collapse or melt-back of the cake
- Optimizing freezing and drying cycle times to retain drug stability

🧫 2. Aseptic Processing

Must be processed under Grade A/B cleanroom conditions
Requires aseptic filtration, sterile vials, and validated environmental controls
Any contamination renders batch unusable

💧 3. Reconstitution Requirements

Final product must dissolve rapidly and clearly in sterile water
Difficult to maintain this across all batch sizes and vial strengths
pH and excipient buffers must be tightly controlled

📦 4. Moisture Sensitivity

Even minor exposure to moisture during filling or storage can degrade Imipenem
Requires use of desiccants, sealed vials, and quick lyophilization sealing

🧮 5. Dose Accuracy

Must ensure uniform fill volumes, especially critical in high-potency injectables
Even microgram-level deviation can affect therapy in critically ill patients

🧪 6. Compatibility with Infusion Systems

Drug must remain stable when reconstituted in 0.9% NaCl or 5% dextrose
Interaction with plastics or IV sets must be evaluated to avoid loss of potency

📝 7. Regulatory Burden

Subject to strict scrutiny by authorities like CDSCO, USFDA, EMA
Requires full process validation, sterility assurance level (SAL) testing, and documentation

❓ 14. What are the storage conditions for IMIPENEM AND CILASTATIN SODIUM STERILE manufactured by Swapnroop Drugs and Pharmaceuticals? ❄️📦

Due to the high sensitivity of Imipenem to heat, moisture, and light, the IMIPENEM AND CILASTATIN SODIUM STERILE formulation requires strict storage controls to preserve its potency, sterility, and stability.

🧊 Recommended Storage Conditions (per pharmacopeial standards):

Parameter	Condition
🌡️ Temperature	2°C to 8°C (Refrigerated, Do Not Freeze)
💧 Humidity	Store in a dry area, protected from moisture
☀️ Light	Protect from light (use amber vials or secondary packaging)
📦 Container	Keep in original sealed vial with desiccant if provided
🔄 Stability (reconstituted)	Use within 4 hours if stored at room temp, or 24 hours if refrigerated

⚠️ Stability Risks If Not Stored Properly:

Hydrolysis of Imipenem in presence of moisture
Loss of sterility and clarity in solution
Degradation into inactive or toxic metabolites
Color change in solution (yellowing indicates breakdown)

❗ Special Instructions:

Do not freeze the reconstituted solution – it may cause drug crystallization
If not used immediately after reconstitution, store refrigerated and discard after 24 hours
Do not use solution if cloudy or contains particulates

❓ 15. What is the packaging for IMIPENEM AND CILASTATIN SODIUM STERILE manufactured by Swapnroop Drugs and Pharmaceuticals? 📦🧴

The packaging is designed to maintain sterility, light protection, and moisture control, while ensuring safe and easy administration by healthcare professionals.

📦 Primary Packaging (per vial):

Component	Details
🧴 Vial	Type I borosilicate glass vial, 20 or 50 mL volume
🧷 Stopper	Butyl rubber closure, siliconized, steam-sterilized
💍 Seal	Aluminum cap with flip-off seal for tamper evidence
🧁 Contents	Lyophilized powder (Imipenem + Cilastatin Sodium)
📃 Label	Contains strength, batch no., expiry, and reconstitution instructions

📦 Secondary Packaging:

Element	Purpose
📦 Mono-carton box	Holds single vial with leaflet
📜 Insert/leaflet	Contains instructions for reconstitution & IV use
🧊 Outer box	Holds multiple mono-cartons for hospital supply
🧼 Sterility Assurance	Gamma-sterilized components; outer box labeled as sterile

🚚 Shipping & Handling:

Shipped under cold chain (2°C–8°C) with temperature indicators
Handled using validated packaging systems with humidity control
Ideal for institutional supply, ICUs, emergency care kits

16. What is the shelf life of IMIPENEM AND CILASTATIN SODIUM STERILE manufactured by Swapnroop Drugs and Pharmaceuticals? 🧪⏳

The shelf life of IMIPENEM AND CILASTATIN SODIUM STERILE manufactured by Swapnroop Drugs & Pharmaceuticals is typically:

🔒 24 months (2 years) from the date of manufacture,
provided it is stored under recommended refrigerated conditions (2°C to 8°C), protected from light and moisture.

📋 Shelf Life Details:

Condition	Shelf Life
❄️ Unopened, lyophilized vial	24 months at 2–8°C in sealed packaging
💧 After reconstitution (RT)	Use within 4 hours at room temperature
❄️ After reconstitution (Refrigerated)	Use within 24 hours at 2–8°C
🚫 Do not freeze	Freezing can cause crystallization or potency loss

📦 Factors that Ensure Full Shelf Life:

Proper cold chain storage during transit and warehousing
Use of sealed, light-protective packaging
Humidity-controlled storage area
Avoidance of repeated temperature fluctuations

🧪 Stability Testing Conducted As Per:

ICH Q1A(R2) – Stability Testing of New Drug Substances and Products
Real-time and accelerated stability studies performed at:
- 25°C/60% RH (long-term)
- 40°C/75% RH (accelerated)

✅ Indications of Expiry or Degradation:

Yellow to brown discoloration of powder or solution
Foul odor upon reconstitution
Cloudiness or particulate matter in solution
Delay in complete reconstitution (>5 minutes)