📘 **Comprehensive Guide on Zolpidem Tartrate API Manufactured by Swapnroop Drugs & Pharmaceuticals** 💊🌙✨

 

Q1 — What is Zolpidem Tartrate API (manufactured by Swapnroop Drugs & Pharmaceuticals)? — 💤🔬✨

Short definition (one line):
Zolpidem tartrate API is the active pharmaceutical ingredient used to make zolpidem-containing hypnotic (sleep) medications — a non-benzodiazepine GABA_A receptor modulator prescribed for short-term treatment of insomnia. 🌙💊

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Chemical & identity snapshot 🧩

• Common name: Zolpidem tartrate (API is the zolpidem base often supplied as the tartrate salt).

• IUPAC name (zolpidem): N,N,6-trimethyl-2-p-tolylimidazo[1,2-a]pyridine-3-acetamide (tartrate is the salt form).

• Molecular formula (zolpidem base): C19H21N3O

• CAS number (zolpidem tartrate): 82626-48-0 (tartrate salt identifiers are commonly used in regulatory docs). 🔎

• Appearance: White to off-white crystalline powder (tartrate salt), free-flowing when properly dried. ❄️

If you need exact molar mass or alternate identifiers for regulatory filings, I can add them.

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Pharmacology — mechanism of action ⚙️🧠

• Mechanism: Zolpidem is a positive allosteric modulator of GABA_A receptors, with preferential binding to the α1 subunit. This potentiates GABAergic inhibition in the CNS and produces hypnotic (sleep-inducing) effects.

• Classification: Non-benzodiazepine “Z-drug” hypnotic (different chemical class but acts on the benzodiazepine binding site of GABA_A). 🧬

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Therapeutic use (clinical role) 🩺🌙

• Primary indication: Short-term management of insomnia — particularly for difficulty initiating sleep.

• Typical clinical goal: Reduce sleep latency (time to fall asleep), and in some formulations help maintain sleep for a limited duration. ⏱️

• Use constraints: Usually recommended for short durations (a few weeks) due to tolerance, dependence, and next-day impairment risks.

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Key pharmaceutical attributes and why the API matters ✅

• Salt form (tartrate) improves aqueous solubility and stability versus the free base, aiding formulation into tablets and oral dispersible forms.

• Particle size & crystal form influence dissolution rate, content uniformity, and bioavailability — critical for a molecule with rapid onset expectations.

• High purity & controlled residual solvents ensure patient safety and predictable pharmacokinetics. 🧪

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Safety profile & precautions ⚠️

• Common adverse effects: Drowsiness, dizziness, headache, somnolence, nausea, and coordination impairment. 😴

• Serious/important risks: Complex sleep-related behaviors (sleepwalking, sleep-driving), next-day impairment, risk of dependence and withdrawal with prolonged use, and potential for respiratory depression especially when combined with CNS depressants (alcohol, opioids). 🚨

• Contraindications/Cautions: Severe hepatic impairment (dose adjustment or avoidance), history of complex sleep behaviors, concomitant use with strong CYP3A4 inhibitors/inducers may alter exposure. Use with caution in elderly (increased sensitivity; fall risk). 🩹

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Formulation & dosing relevance 💊

• Typical strengths: 5 mg and 10 mg immediate-release tablets (strengths vary by market and patient population).

• Onset expectation: Rapid absorption → fast onset of action; formulations are designed to dissolve and release zolpidem quickly for sleep initiation. ⚡

• Implication for API: Fast dissolution performance required — particle engineering (micronization) and appropriate salt/crystal form control are important.

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Quality & regulatory expectations 🏷️📋

Customers expect zolpidem tartrate API to be supplied with:

• Certificate of Analysis (CoA) showing assay, impurities, residual solvent results, moisture content, and microbial limits.

• GMP compliance, batch traceability, and stability data suitable for dossier submission in regulated markets. 🏛️

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Packaging & storage (API commercial view) 📦🌡️

• Packaging: Double-lined polyethylene bags inside HDPE or fiber drums (desiccant and light-resistant inner liner if moisture/light sensitive).

• Storage: Cool, dry place; typically below 25°C and protected from moisture/light to maintain potency and prevent degradation. 🧊

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Why Swapnroop’s supply matters to buyers 🤝

Buyers look for: robust impurity control, reproducible particle size, validated analytical methods, and documentation for regulatory filings. A consistent, pharmacopeial-grade zolpidem tartrate API from Swapnroop enables reliable finished products (tablets/ODTs) that perform predictably in patients. 📦✅

2️⃣ What is Zolpidem Tartrate API by Swapnroop Drugs & Pharmaceuticals used for?

💤 Primary Use:
Zolpidem Tartrate API is used in the manufacturing of hypnotic medications designed to treat insomnia, especially for patients who have difficulty falling asleep or maintaining sleep. 🛏️

🧠 Pharmacological Role:
It acts on the GABA-A receptor complex, enhancing the activity of GABA (the brain’s main inhibitory neurotransmitter). This results in CNS depression, leading to sedation, relaxation, and sleep induction.

💊 Therapeutic Applications:

• Treatment of short-term insomnia 💤

• Managing sleep onset difficulties ⏱️

• As part of pre-anesthetic medication in some clinical settings 💉

⚠️ Note: Long-term use is discouraged due to potential for tolerance and dependence.

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3️⃣ What are the physicochemical properties of Zolpidem Tartrate API manufactured by Swapnroop Drugs & Pharmaceuticals?

🧪 Physicochemical Profile:

• Chemical Name: N,N,6-Trimethyl-2-(4-methylphenyl)imidazo[1,2-a]pyridine-3-acetamide tartrate

• Molecular Formula: C19H21N3O·C4H6O6

• Molecular Weight: ~764.9 g/mol (tartrate salt) ⚖️

• Appearance: White to off-white crystalline powder ❄️

• Odor: Odorless

• Taste: Slightly bitter

• Solubility:

  • Freely soluble in water and methanol 💧

  • Sparingly soluble in ethanol 🍶

  • Practically insoluble in non-polar solvents (e.g., hexane)

• Melting Point: ~193–196°C 🌡️

• pKa: 6.2 (weakly basic)

• Log P: ~2.2 (moderate lipophilicity)

• Hygroscopicity: Slightly hygroscopic; requires dry storage 🧴

🔬 These properties make it ideal for oral solid dosage forms, as the tartrate salt ensures good solubility and bioavailability.

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4️⃣ How is Zolpidem Tartrate API manufactured (synthesized) by Swapnroop Drugs & Pharmaceuticals?

⚗️ Synthesis Overview:
Zolpidem Tartrate is synthesized through a multi-step organic synthesis involving condensation, cyclization, and amidation reactions. Below is a general outline (simplified):

1. Formation of Imidazopyridine Core

   • The reaction between 2-amino-5-methylpyridine and benzoylacetate derivatives forms the imidazo[1,2-a]pyridine ring system 🔄

2. N-Methylation

   • The imidazopyridine intermediate undergoes methylation at the nitrogen atom using a suitable methylating agent like dimethyl sulfate or methyl iodide 🧪

3. Acetamide Formation

   • Introduction of the acetamide side chain via acetylation or amidation reactions creates the active moiety responsible for hypnotic activity 🧬

4. Salt Formation (Tartrate)

   • The free base is converted into Zolpidem Tartrate by reaction with tartaric acid in a suitable solvent (e.g., ethanol or isopropanol). This enhances solubility and stability 💧

5. Purification and Crystallization

   • The final API is purified by recrystallization and dried under controlled conditions to achieve pharmacopeial purity standards. 🌡️

🏭 Swapnroop’s Process Advantage:

• Uses GMP-compliant synthesis

• Validated analytical controls at each step

• Focus on low residual solvent and controlled polymorphism for high-quality, stable API ✅

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5️⃣ What are the different dosage forms of Zolpidem Tartrate manufactured using the API?

💊 Common Dosage Forms:

1. Immediate-Release Tablets (5 mg, 10 mg) — for quick sleep induction 🕓

2. Extended-Release Tablets (ER) — for patients with difficulty maintaining sleep 🌙

3. Oral Disintegrating Tablets (ODTs) — dissolve rapidly without water 💧

4. Sublingual Tablets — for rapid absorption under the tongue 👅

5. Spray formulations or drops — newer forms for fast onset 💨

🧩 Formulation depends on:

• Desired onset and duration of action

• Patient age and swallowing ability

• Compliance and pharmacokinetic profile

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6️⃣ How are Zolpidem Tartrate dosage forms prepared?

⚗️ General Preparation Process for Tablets (Example):

Step 1 – Blending:
Mix Zolpidem Tartrate API with excipients such as lactose monohydrate, microcrystalline cellulose, and crosscarmellose sodium to ensure uniform distribution. ⚙️

Step 2 – Granulation:
Perform wet granulation using a binder (e.g., povidone) or direct compression, depending on tablet type. 🧪

Step 3 – Drying:
Dry the granules at low temperature (<60°C) to maintain stability and prevent degradation. 🌬️

Step 4 – Lubrication:
Add lubricants like magnesium stearate and colloidal silicon dioxide to improve flow and compression properties. ⚖️

Step 5 – Compression:
Compress into tablets using rotary tablet press machines to achieve uniform hardness and weight. 💊

Step 6 – Coating (optional):
Film-coat for controlled release, protection from moisture, or taste masking (especially in ODTs). 🎨

Step 7 – Packaging:
Pack in blister packs or HDPE bottles with desiccants to ensure stability and protect from moisture. 📦

7️⃣ What is the appropriate dosage form of Zolpidem Tartrate? 💊📏

The appropriate dosage form depends on patient needs, onset requirements, and convenience:

• Immediate-Release (IR) Tablets:

  • Most common for short-term insomnia treatment 🌙

  • Allows rapid sleep induction within 15–30 minutes

• Extended-Release (ER) Tablets:

  • Suitable for patients with difficulty maintaining sleep

  • Designed for sustained plasma levels overnight ⏱️

• Orally Disintegrating Tablets (ODTs):

  • Ideal for patients with swallowing difficulties

  • Dissolve rapidly on the tongue 💧

• Sublingual Tablets / Sprays:

  • Rapid absorption for immediate effect 👅⚡

💡 Summary:
For most adults, immediate-release tablets are the preferred dosage form for Zolpidem, while ER or ODT forms are used based on patient-specific needs and ease of administration. ✅

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8️⃣ When should Zolpidem Tartrate API (as medication) be taken? ⏰🌙

Although API itself isn’t consumed directly, formulations using Zolpidem Tartrate should follow:

• Timing: Take immediately before bedtime (ensure 7–8 hours of sleep opportunity) 🛏️

• With or without food: Can be taken on an empty stomach for faster onset; food may delay absorption 🍽️

• Adults: Typical dose 5–10 mg for immediate-release tablets, 6.25–12.5 mg for extended-release, depending on clinical response

• Elderly/renally impaired: Lower doses recommended due to increased sensitivity ⚖️

⚠️ Precautions:

• Avoid alcohol and other CNS depressants

• Do not take if planning to wake up within 6–8 hours

• Avoid activities requiring alertness the next morning (driving, operating machinery)

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9️⃣ What are the effects and side effects of Zolpidem Tartrate? ⚡😴

Therapeutic Effects:

• Sleep induction: Reduces time to fall asleep

• Sleep maintenance: In extended-release forms, improves total sleep duration 🌙

• Minimal muscle relaxation and anxiolysis compared to benzodiazepines — reduces daytime sedation risk

Common Side Effects:

• Drowsiness, fatigue 😴

• Dizziness, headache

• Gastrointestinal issues: nausea, diarrhea

• Mild amnesia or forgetfulness

Serious or Rare Side Effects:

• Complex sleep behaviors: sleepwalking, sleep-driving 🚨

• Next-day sedation or impaired coordination

• Allergic reactions or rash

• Rare: hallucinations or mood changes

💡 Management Tips:

• Take lowest effective dose

• Adequate sleep duration reduces next-day effects

• Monitor elderly patients for falls or confusion

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🔟 How is Zolpidem Tartrate API tested? 🧪✅

Quality control ensures purity, potency, and safety before formulation:

• Identity Tests:

  • IR spectroscopy, UV-Vis spectroscopy, HPLC retention time to confirm chemical structure

• Assay / Potency:

  • HPLC determines API content (typically 98–102% of label claim)

• Impurity Profile:

  • HPLC or LC-MS detects organic impurities and degradation products

  • Impurities controlled within ICH limits (<0.10% individually, <0.5% total)

• Residual Solvent Testing:

  • Gas chromatography ensures solvents from synthesis are below safe limits

• Physical Tests:

  • Melting point, loss on drying, water content

• Microbiological Testing:

  • Total viable count, absence of pathogens (for sterility if needed)

📋 Outcome:
Every batch is released with a Certificate of Analysis (CoA) detailing these results, ensuring regulatory compliance. ✅

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1️⃣1️⃣ What tests are performed on Zolpidem Tartrate API? 🔍🧫

Category	Test	Purpose / Acceptance Criteria
Identity	IR, UV-Vis, HPLC retention	Confirm chemical structure
Assay / Potency	HPLC	98–102% of label claim
Related Substances	HPLC / LC-MS	Individual <0.1%, total <0.5%
Residual Solvents	GC	Within ICH Q3C limits
Heavy Metals	ICP-OES	≤10 ppm
Loss on Drying	Gravimetric	≤0.5%
Melting Point	Capillary	~193–196°C
Water Content	Karl Fischer	≤0.5%
Microbial Limits	Plate count, absence of pathogens	Within pharmacopeial limits
Polymorphism	XRPD / DSC	Confirm correct crystalline form
Particle Size Distribution	Laser diffraction	Ensure uniformity for formulation

💡 Summary:
Zolpidem Tartrate API manufactured by Swapnroop Drugs & Pharmaceuticals undergoes rigorous chemical, physical, and microbiological testing to guarantee purity, stability, and suitability for formulation into hypnotic medications. 🌙💊

1️⃣2️⃣ What are the challenges in manufacturing Zolpidem Tartrate API? ⚗️🏭

Producing high-quality Zolpidem Tartrate API involves several technical and regulatory challenges:

1. Multi-step synthesis complexity 🔄

   • Requires condensation, cyclization, and amidation reactions.

   • Each step must be tightly controlled to prevent side reactions or impurity formation.

2. Impurity control 🧪

   • By-products from methylation, amidation, or cyclization can form.

   • Impurities must be kept within ICH guidelines (≤0.1% individually, ≤0.5% total).

3. Polymorphism control 💎

   • Zolpidem tartrate can crystallize in multiple forms.

   • Only a specific polymorph is pharmaceutically acceptable; controlling crystallization is critical.

4. Moisture sensitivity 💧

   • Slightly hygroscopic; moisture can affect flow, assay, and stability.

   • Requires controlled drying and low-humidity storage.

5. Scale-up challenges ⚙️

   • Maintaining consistent yield, purity, and particle size from lab to industrial scale is demanding.

6. Regulatory compliance 🏛️

   • All raw materials, solvents, and intermediates must meet GMP standards.

   • Residual solvents, heavy metals, and microbial limits must be documented for international regulatory submission.

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1️⃣3️⃣ What are the challenges in manufacturing Zolpidem dosage forms? 💊⚙️

Formulating zolpidem into tablets, ODTs, or ER forms presents additional hurdles:

1. Poor water solubility 💧

   • Zolpidem has moderate solubility; needs micronization, solid dispersions, or surfactants to enhance bioavailability.

2. Content uniformity ⚖️

   • Fine particle size can lead to non-uniform mixing, especially in ODTs and ER tablets.

   • Requires precise blending and granulation.

3. Stability during storage 🌡️

   • Sensitive to moisture and light, which can affect dissolution rate and potency.

   • Film coatings and moisture-proof packaging are essential.

4. Excipients compatibility 🧩

   • Some binders or fillers may interact with API and alter dissolution or stability.

   • Extensive pre-formulation studies are needed.

5. Controlled-release formulations ⏱️

   • ER tablets require careful polymer matrix selection and coating thickness control to maintain predictable drug release kinetics.

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1️⃣4️⃣ What are the storage conditions for Zolpidem Tartrate API? 📦🌡️

To maintain stability, potency, and purity:

• Temperature: Store in a cool environment (<25°C) 🧊

• Moisture: Protect from humidity (slightly hygroscopic) 💧

• Light: Keep away from direct sunlight ☀️

• Containers: Use airtight, light-resistant HDPE drums or polyethylene-lined fiber drums 🛢️

• Handling: Avoid prolonged exposure to air or strong oxidizing agents ⚗️

Proper storage ensures chemical integrity and consistent performance during formulation. ✅

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1️⃣5️⃣ What is the packaging for Zolpidem Tartrate API? 📦🎀

Packaging specifications for commercial API supply:

• Inner lining: Double-layer polyethylene bags to prevent moisture ingress 🧴

• Outer container: HDPE drum or fiberboard drum (25 kg typical) 🛢️

• Labeling: Batch number, manufacturing and expiry date, handling instructions, regulatory compliance marks 🏷️

• Special considerations:

  • Desiccants may be included to control residual moisture

  • Light-protective liners for long-term storage

🌿 Swapnroop Drugs & Pharmaceuticals ensures:

• GMP-compliant packaging

• Protection during storage and transport

• Regulatory-ready CoA and documentation

1️⃣6️⃣ What is the shelf life of Zolpidem Tartrate API? 🕒

The typical shelf life of Zolpidem Tartrate API is 3 to 5 years when stored under recommended conditions. Proper shelf life ensures that the API maintains potency, purity, and stability throughout its intended use.

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Factors influencing shelf life:

1. Temperature control 🌡️

   • Must be stored below 25°C in a cool environment.

2. Moisture protection 💧

   • Slightly hygroscopic; moisture can reduce stability or affect particle flow.

3. Light exposure ☀️

   • Protected from direct sunlight to avoid degradation.

4. Packaging quality 📦

   • HDPE/fiber drums with double polyethylene liners preserve integrity.

5. Residual solvents & excipients ⚗️

   • Proper purification and drying ensure minimal degradation risk.

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Stability confirmation 🔬

• Accelerated and long-term stability studies are performed following ICH Q1A(R2) guidelines.

• Parameters monitored: assay, impurity profile, moisture content, polymorphic form, and color/appearance.

• Ensures API remains within specification limits over the declared shelf life. ✅

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💡 Summary:
When stored under recommended conditions, Zolpidem Tartrate API from Swapnroop Drugs & Pharmaceuticals is stable, pure, and fully potent for 3–5 years, making it suitable for long-term formulation and distribution worldwide. 🌍💊