🔹 “Comprehensive Overview of Zuclopenthixol Acetate API Manufactured by Swapnroop Drugs & Pharmaceuticals”

💊 Q1 — What is Zuclopenthixol Acetate manufactured by Swapnroop Drugs & Pharmaceuticals?

Zuclopenthixol acetate (API) manufactured by Swapnroop Drugs & Pharmaceuticals is a pharmaceutical-grade active ingredient from the thioxanthene class of typical antipsychotics. It is supplied as an API for use primarily in injectable intramuscular (IM) formulations intended for the short-term management of acute psychomotor agitation, severe agitation in psychosis, or when rapid tranquilization is required. 🚑🧠

🧬 Pharmacologic class & mechanism

Class: Typical antipsychotic — thioxanthene derivative.
Primary action: Potent dopamine D₂ receptor antagonism in the central nervous system, which reduces psychotic symptoms (hallucinations, delusions) and controls acute agitation. It also has activity at other receptors (α-adrenergic, histaminic), contributing to sedative and hypotensive effects. ⚖️🧪

🏷️ Typical clinical uses (as API in finished products)

Acute psychomotor agitation in schizophrenia or other psychotic episodes (short-term IM use).
Rapid tranquilization in emergency/psychiatric settings when oral medication is not feasible.
Note: Zuclopenthixol decanoate is the long-acting depot cousin used for maintenance; acetate form is used for short-term, rapid control. 🏥⏱️

🧾 Quality & manufacturing profile (Swapnroop)

GMP manufacturing: Produced in compliance with Good Manufacturing Practices to meet pharmaceutical quality standards. 🏭✔️
API Grade: Pharmaceutical / injectable-grade suitable for sterile IM dosage forms after appropriate formulation and sterilization by the contract manufacturer.
Purity & QC: Provided with certificate of analysis (CoA) showing assay, impurity profile, residual solvents, and other QC data per pharmacopeial expectations. 🔬📜

🔬 Physical characteristics (typical attributes)

Appearance: Usually a white to off-white crystalline powder (dependent on polymorph).
Solubility: Poorly soluble in water; more soluble in organic solvents (alcohols, chloroform). (Formulation requires suitable solvent system or suspension strategy for IM use.)
Stability: Sensitive to moisture and light—requires controlled storage and appropriate protective packaging. 🌡️🛡️

🏷️ Regulatory & safety notes

Intended supply: For licensed pharmaceutical manufacturers who convert the API into finished sterile IM products. Swapnroop’s regulatory documentation (DMF/CTD extracts) supports partner regulatory filings where required. 🗂️✔️
Handling: API must be handled in controlled manufacturing environments with appropriate PPE; injectable formulations must meet sterility and particulate limits. 🧤🔬

✅ In short

Zuclopenthixol acetate API from Swapnroop is a high-quality, GMP-manufactured active ingredient used to make short-acting intramuscular antipsychotic products for rapid control of acute agitation in psychosis. Swapnroop supplies the API with standard QC data and storage/handling guidance so formulation partners can produce safe, efficacious sterile preparations. 🌍💉

🧩 Q2. What is Zuclopenthixol Acetate by Swapnroop Drugs & Pharmaceuticals used for?

Zuclopenthixol Acetate is a short-acting injectable antipsychotic agent used to rapidly control acute psychotic symptoms and agitation in patients with disorders like schizophrenia or mania. 🧠💉

🔹 Therapeutic Applications

Used for acute management of severe psychosis and violent or aggressive behavior. ⚡
Administered in psychiatric emergencies to calm agitated patients when oral therapy is not possible. 🚑
Acts within a few hours, giving rapid symptom control and allowing transition to maintenance therapy later. ⏱️➡️💊

🌍 Clinical Benefits

Provides tranquilization without deep sedation.
Improves compliance by offering quick relief.
Allows safer handling of acutely disturbed patients.

🧠 In short: It’s a powerful short-term tranquilizer for emergency psychiatric use, bridging the gap before long-term treatment begins.

⚗️ Q3. What are the physicochemical properties of Zuclopenthixol Acetate manufactured by Swapnroop Drugs & Pharmaceuticals?

🔬 Physicochemical Characteristics

Property	Description
Chemical Name	Cis-(Z)-4-[3-(2-chloro-9H-thioxanthen-9-ylidene)propyl]-N,N-dimethylpiperazine-1-ethanamine acetate
Molecular Formula	C₂₃H₂₉ClN₂OS·C₂H₄O₂
Molecular Weight	≈ 461.0 g/mol
Appearance	White to off-white crystalline powder ❄️
Solubility	Insoluble in water 💧; soluble in ethanol, chloroform, and methanol
Melting Point	Around 144–150 °C 🌡️
pKa	Approximately 8.9 (basic compound) ⚖️
Partition Coefficient (log P)	~4.5 → Lipophilic molecule 🧪

💡 Key Note

The acetate salt form enhances solubility in organic solvents and provides better stability for injectable formulations compared to free base forms. 🔐

⚙️ Q4. How is Zuclopenthixol Acetate manufactured by Swapnroop Drugs & Pharmaceuticals synthesized?

Swapnroop Drugs & Pharmaceuticals follows a GMP-compliant multistep synthesis process ensuring purity, safety, and regulatory compliance. 🏭⚗️

🧬 Simplified Synthesis Pathway

Starting Material: Thioxanthene derivative → undergoes chlorination to form 2-chloro-9H-thioxanthene.
Side-Chain Introduction: Reaction with a piperazine derivative to attach the dimethylaminoethyl chain.
Formation of Zuclopenthixol Base: Controlled condensation to produce the active thioxanthene base.
Salt Formation: Conversion to acetate salt using acetic acid → yields Zuclopenthixol Acetate.
Purification & Crystallization: Multiple recrystallizations and solvent washes ensure high purity (>99%).
Drying & Milling: Final product is dried under controlled conditions and micronized for uniform particle size.

🧾 Quality Checks at Each Stage

✅ Assay & impurity analysis
✅ Residual solvent testing
✅ Particle size distribution
✅ Moisture content

🔬 Result: A pharmacopeia-grade API suitable for injectable dosage formulation.

💊 Q5. What are the different dosage forms of Zuclopenthixol Acetate manufactured by Swapnroop Drugs & Pharmaceuticals?

Swapnroop manufactures the API (not finished dose), which is supplied to formulation partners for the following dosage forms:

🧴 Available Formulations (in market)

Intramuscular Injection (IM) – Suspension form (10 mg/mL or 25 mg/mL). 💉
Combination Kits – Used with Zuclopenthixol decanoate (for transition from acute to maintenance phase). 🔁

📦 Formulation Intent

Short-acting IM injection for rapid calming effects (acetate).
Long-acting depot (decanoate) for maintenance therapy.

🧠 The acetate form acts fast (within hours), ideal for acute situations, while decanoate provides prolonged control.

⚗️ Q6. How are Zuclopenthixol Acetate dosage forms prepared?

💉 Typical IM Suspension Manufacturing Steps

API Dispersion: Zuclopenthixol acetate is dispersed in a sterile oil-based vehicle (e.g., fractionated coconut oil).
Addition of Stabilizers: Surfactants or wetting agents (like polysorbates) are added for uniformity.
Homogenization: The suspension is homogenized to ensure even particle distribution. ⚙️
Sterile Filtration or Aseptic Processing: To ensure sterility and freedom from microorganisms. 🔬
Filling & Sealing: The sterile suspension is filled into amber glass ampoules or vials, then sealed under aseptic conditions. 💡
Final Testing: Each batch undergoes tests for assay, sterility, particulate matter, and uniformity before release. 📑

🌿 Note: Swapnroop provides the API and formulation guidance — actual sterile production is done by formulation partners under GMP sterile facilities.

💊 Q7. What is the appropriate dosage form of Zuclopenthixol Acetate manufactured by Swapnroop Drugs & Pharmaceuticals?

The appropriate dosage form for Zuclopenthixol Acetate is the short-acting intramuscular (IM) injection. 💉

⚙️ Why IM Form?

Provides rapid onset (within 2–4 hours) ⏱️
Useful for patients unable/unwilling to take oral medication 🚫💊
Delivers controlled release over 1–3 days, bridging to longer-acting therapy (Zuclopenthixol decanoate). 🔁

📦 Typical Strengths

10 mg/mL
25 mg/mL (commonly used for severe agitation)

🧠 Summary

✅ Form: Intramuscular suspension
✅ Onset: Rapid (2–4 hours)
✅ Duration: Up to 3 days
✅ Indication: Acute agitation in psychosis

🕒 Q8. When should Zuclopenthixol Acetate API manufactured by Swapnroop Drugs & Pharmaceuticals be taken?

Zuclopenthixol Acetate is not taken orally — it is a short-acting intramuscular (IM) injection, given only by healthcare professionals. 💉🏥

⏱️ Timing & Administration

Administered in acute situations where a patient is severely agitated, violent, or psychotic. ⚡
Typically given in a hospital or psychiatric emergency unit under medical supervision.
The effect starts within 2–4 hours and lasts up to 48–72 hours, providing control until oral or long-acting therapy begins. ⏳

📋 Dosage Guidelines (general clinical practice)

Initial IM dose: Usually 50–150 mg, adjusted based on severity.
Repeat dose: May be given after 2–3 days, if needed.
Transition: Once calm, the patient is switched to oral or depot antipsychotic (like Zuclopenthixol decanoate). 🔁

⚠️ Note: The API itself is used in formulation — actual dosing depends on the finished drug product and physician’s prescription.

💥 Q9. What are the effects and side effects of Zuclopenthixol Acetate manufactured by Swapnroop Drugs & Pharmaceuticals?

🌿 Therapeutic Effects (Positive)

Rapid tranquilization and calming effect 😌
Reduction of psychotic symptoms (hallucinations, delusions) 🧠
Improved behavior and reduced aggression in acutely disturbed patients ⚖️
Restores cooperation and safety in psychiatric settings 🏥

⚠️ Possible Side Effects (Depend on Dose & Sensitivity)

Category	Common Side Effects
🧠 Neurological	Drowsiness, dizziness, extrapyramidal symptoms (muscle stiffness, tremor)
💓 Cardiovascular	Hypotension, tachycardia, QT prolongation (rare)
😴 Sedation	Mild-to-moderate sedation (useful in acute agitation)
🧍‍♂️ General	Dry mouth, blurred vision, constipation, urinary retention
🌡️ Injection Site	Pain or inflammation at injection site (usually mild)

💡 Precautions

Should not be mixed with alcohol or other sedatives.
Caution in elderly and patients with cardiovascular disease.
Continuous monitoring during and after injection is essential. 🔬

🧪 Q10. How is Zuclopenthixol Acetate manufactured by Swapnroop Drugs & Pharmaceuticals tested?

Swapnroop ensures each batch of Zuclopenthixol Acetate API undergoes comprehensive quality control (QC) and analytical testing following GMP and pharmacopeial standards. 🧬✔️

🧫 In-Process & Final Tests Include:

Identification Tests:
- Infrared Spectroscopy (IR)
- UV Spectrum or TLC fingerprint
- Chemical tests confirming acetate salt formation 🧪
Assay (Content):
- HPLC determination for API purity (should be ≥99%) 📊
Related Substances:
- Detection of impurities and degradation products using HPLC.
Loss on Drying / Moisture Content:
- Karl Fischer or oven method 💧
Residue on Ignition / Heavy Metals:
- Confirms absence of inorganic contaminants.
Residual Solvent Analysis:
- GC method to detect traces of organic solvents used in synthesis. 🔬
Particle Size Analysis:
- Ensures proper dispersion characteristics for suspension formulations. ⚙️

📜 Documentation

Each batch comes with a Certificate of Analysis (CoA) and Batch Manufacturing Record (BMR) containing:

Assay value
Impurity profile
Lot number
Date of manufacture
Storage recommendations

✅ Result: A pharmacopeia-compliant API meeting IP/BP/EP/USP standards.

🧬 Q11. What tests are performed on Zuclopenthixol Acetate manufactured by Swapnroop Drugs & Pharmaceuticals?

Here’s a list of routine QC tests performed to ensure API quality, purity, and compliance:

🧪 Test	🧾 Purpose
Description / Appearance	Confirms visual consistency of batch
Identification (IR / UV)	Confirms chemical identity
Assay (HPLC)	Measures active content (purity ≥99%)
Related Substances	Detects impurities and degradation products
Water Content	Ensures low moisture (typically <1.0%)
pH (solution test)	Confirms expected acidity/basicity range
Residual Solvents (GC)	Verifies safe solvent levels per ICH Q3C
Heavy Metals / Elemental Impurities	Ensures compliance with ICH Q3D
Melting Point & DSC	Confirms physical purity and polymorphic stability
Microbial Limits (for sterile grade)	Ensures absence of pathogens 🧫

📦 Final QC Approval only after all parameters meet internal specifications and pharmacopeial limits.

⚗️ Q12. What are the challenges in manufacturing Zuclopenthixol Acetate API?

Producing Zuclopenthixol Acetate requires precise control of reaction conditions and stringent purification, as it is a complex heterocyclic compound. ⚙️

⚠️ Key Manufacturing Challenges

Impurity Control:
- Multiple synthetic steps increase risk of process impurities and unreacted intermediates. 🔬
Moisture Sensitivity:
- The acetate salt is hygroscopic, requiring controlled humidity (<40% RH). 🌫️
Crystallization & Polymorphism:
- Ensuring consistent crystal form for reproducible bioavailability and stability. 💎
Residual Solvents:
- Proper solvent recovery and drying needed to meet ICH limits. 🧯
Yield Optimization:
- Complex synthesis requires optimization to ensure cost-effectiveness without compromising purity. ⚗️
Regulatory Documentation:
- Maintaining comprehensive DMF and CTD data for global regulatory markets. 🌍📑

💉 Q13. What are the challenges in manufacturing Zuclopenthixol Acetate dosage forms?

The formulation of Zuclopenthixol Acetate IM suspension is equally demanding, requiring control over sterility, viscosity, and particle uniformity. 🧴⚙️

🧪 Major Formulation Challenges

Sterile Processing:
- Must be manufactured under aseptic conditions (Class 100/Grade A cleanrooms). 🧼
Particle Size Control:
- Improper size causes sedimentation or clogging of injection needles. 💉
Suspension Stability:
- Maintaining uniform dispersion in oil-based vehicle (e.g., coconut oil) is critical. 🌿
Viscosity Management:
- Too viscous → injection difficulty; too thin → poor depot effect. ⚖️
Sterility Assurance:
- Final product must pass sterility, endotoxin, and particulate tests. 🔬
Packaging Compatibility:
- Glass vial and stopper must be compatible with oil-based formulation. 🧴
Regulatory Validation:
- Requires validated process per GMP and ICH Q8–Q10 standards. 📋

✅ Outcome: A safe, uniform, and stable injectable dosage form that provides rapid tranquilization with predictable pharmacokinetics.

❄️ Q14. What are the storage conditions for Zuclopenthixol Acetate manufactured by Swapnroop Drugs & Pharmaceuticals?

Proper storage is crucial to maintain potency, purity, and stability of Zuclopenthixol Acetate API. 🧪🛡️

🌡️ Recommended Storage Conditions

Parameter	Requirement
Temperature	Store at 20–25°C (room temperature)
Humidity	Keep <40% relative humidity 🌫️
Light Protection	Store in dark or amber containers ☀️❌
Container Type	Airtight HDPE drums with inner polyethylene liners 📦
Handling	Avoid prolonged exposure to air or moisture during weighing/dispensing 🧤
Transport	Use temperature-controlled and moisture-free conditions 🚚

⚠️ Note: Improper storage (high humidity or light) may cause degradation, color change, or reduced potency.

📦 Q15. What is the packaging for Zuclopenthixol Acetate manufactured by Swapnroop Drugs & Pharmaceuticals?

🏭 API Packaging

Primary container: HDPE drums with double polyethylene liners.
Closure: Airtight and tamper-evident 🔒
Labeling: Includes product name, batch number, manufacturing date, expiry date, and storage instructions 🏷️
Capacity: Typically 1 kg, 5 kg, 10 kg, or 25 kg drums depending on client requirements.

🌍 Export / Transport Packaging

Cartons with shock-resistant padding
Desiccant sachets to maintain low humidity 🌿
Compliant with UN packaging regulations for safe shipment

💊 Formulated Product Packaging (IM Injection)

Primary: Amber glass vials or ampoules
Secondary: Cartons with batch number, strength, and storage instructions
Protects from light, moisture, and contamination 💉

⏳ Q16. What is the shelf life of Zuclopenthixol Acetate manufactured by Swapnroop Drugs & Pharmaceuticals?

🧬 Shelf Life of API

Standard: 36 months (3 years) from date of manufacture 📆
Storage: 20–25°C, protected from light and moisture
Packaging Integrity: Must remain sealed in original HDPE drums

🔬 Stability Studies

Accelerated: 40°C ±2°C / 75% RH ±5% for 6 months
Long-term: 25°C ±2°C / 60% RH ±5% for 36 months
Parameters monitored: Assay, impurities, moisture content, and physical appearance

✅ Result: API maintains ≥99% purity, free from degradation, with stable crystallinity.

⚠️ Note

Once drum is opened or improperly stored, effective shelf life may decrease.
Always follow Swapnroop’s storage and handling guidelines to ensure product quality. 🌡️📦